Metallosis is commonly associated with magnetically controlled growing rods; results from an independent multicentre explant database.

PURPOSE: Determine the incidence of metallosis around MAGEC rods. METHODS: A multicentre explant database was searched to identify cases with complete intraoperative findings at rod removal. Surgeons removing rods detailed the presence or absence of tissue metallosis associated with rods. More recently surgeons measured the 'length' of tissue metallosis. Prior to rod disassembly, the majority underwent testing with an external remote controller (ERC). The impact of clinical and explant variables on metallosis was assessed. RESULTS: Sixty-six cases were identified. Mean age at insertion was 8.1 ± 2.3 years with mean duration of implantation 37.6 ± 15.1 months. Tissue metallosis was noted at revision surgery in 52/66 cases (79%). Metallosis was noted more commonly when rods were removed during fusion surgery than rod removal/exchange (97% vs. 58% (p = < 0.01)). The mass at insertion was greater in cases with metallosis (25.9 ± 7.8 kg vs. 21.1 ± 6.2 kg, p = 0.04). Length of tissue metallosis was reported for 45 rods, median 9 cm (range 1-25). Metallosis was noted in 43/59 (73%) rods that produced no force and 22/30 (73%) rods that produced some force on ERC activation (p = 0.96). Wear debris was found within the actuator in all rods, and all but 3 rods had damaged O-rings. CONCLUSION: MAGEC rods are associated with tissue metallosis in the majority of cases. It is seen with functional rods as well as failed rods and appears related to wear debris within the actuator and high rates of O-ring failure. Until the implications of metal debris in children are known, we urge caution with the use of this implant.

The NuVasive MAGEC Rod Urgent Field Safety Notice Concerning Locking Pin Fracture: How Does Data From an Independent Explant Center Compare?

STUDY DESIGN: Analysis of explanted MAGnetic Expansion Control (MAGEC) growing rods. OBJECTIVE: The aim of this study was to quantify the rate of locking pin breakage in explanted MAGEC rods and compare with the manufacturer's data. SUMMARY OF BACKGROUND DATA: On June 25, 2019, NuVasive released an Urgent Field Safety Notice stating that MAGEC rods manufactured before March 26, 2015 had a higher than expected locking pin breakage rate of 5%. For rods made on or after that date, no pin breakages had occurred. METHODS: From our independent explant database of 139 explanted MAGEC rods supplied from 10 UK spinal centers (Belfast, Bristol, Birmingham, Edinburgh, Exeter, Leeds, Newcastle, Nottingham, Oxford, and Sheffield) and one Danish center (Aarhus), we divided the rods into those manufactured before March 26, 2015, and those manufactured on or after that date. MAGEC rods were cut open to fully assess internal components including locking pins. From each of the two cohorts, 10 locking pins were selected at random and their diameters were measured using a micrometer. RESULTS: One hundred and five explanted MAGEC rods were made before March 26, 2015 and could be disassembled to allow the locking pin to be examined. Fifty-nine percent (62/105) of these locking pins had fractured. For the MAGEC rods manufactured on or after March 26, 2015, 21% (6/29) were found to have fractured locking pins. Locking pins in MAGEC rods made on or after March 26, 2015 were of a stronger material and a larger diameter. CONCLUSION: Fifty-nine percent of the locking pins in MAGEC rods manufactured before March 26, 2015 had fractured, far greater than the 5% stated in the Urgent Field Safety Notice. Locking pin fracture still occurred in MAGEC rods manufactured on or after that date, in 21% of cases. This contrasted with the 0% reported by the manufacturer. LEVEL OF EVIDENCE: 4.

Spinal Lengthening With Magnetically Controlled Growing Rods: Data From the Largest Series of Explanted Devices.

STUDY DESIGN: Laboratory analysis of explanted MAGnetic Expansion Control (MAGEC) rods. OBJECTIVE: The aim of this study was to identify the in vivo lengthening of MAGEC rods. SUMMARY OF BACKGROUND DATA: Little data is available regarding the lengthening achieved by MAGEC rods. METHODS: Cases were identified from the largest series of independently analyzed explanted MAGEC rods. The in vivo growth of rods was determined by the distance between the first "growth mark" and the actuator. The instrumented spinal lengthening was calculated for each construct. Constructs were considered functional if all rods could lengthen with external remote controller activation and no rods were "telescoping". RESULTS: Fifty-five MAGEC constructs (99 rods) from 53 patients treated at 10 centers were included. The mean age at insertion was 8.5 years with rods implanted a mean of 35 months. Sixty rods were suitable for analysis with mean lengthening 21.7 mm, 8.9 mm/year. Of these 60 rods, three were maximally distracted. Mean instrumented spinal lengthening for 38 suitable cases was 22.1 mm, 8.4 mm/year. This was positively correlated with the duration of implantation (r = 0.34, P = 0.04) but negatively with patient age at insertion (r = -0.35, P = 0.03). The rate of instrumented spinal lengthening was negatively correlated with duration of implantation (r = -0.47, P = 0.004). Of 55 constructs, 34 were nonfunctional at time of removal with nine functional and 12 indeterminate. Functional constructs had been implanted significantly less time (20.0 vs. 39.7 months, P < 0.001) and lengthened less than those nonfunctional (12.3 mm vs. 23.3 mm, P = 0.04). CONCLUSION: This multicenter explant study represents the largest cohort managed with MAGEC rods reported. Rods are very rarely removed having fully lengthened with mean instrumented spinal growth of 22 mm over the implant's life. This may be explained by a high rate of lengthening mechanism failure in received rods after around 3 years in vivo. Our findings question the effectiveness of the MAGEC system and mandate urgent comparative clinical studies. LEVEL OF EVIDENCE: 4.

Force Testing of Explanted Magnetically Controlled Growing Rods.

STUDY DESIGN: Laboratory analysis of explanted MAGnetic Expansion Control (MAGEC) growing rods. OBJECTIVE: The aim of this study was to measure the force produced by explanted MAGEC rods compared with new rods and assess the influence of clinical variables. SUMMARY OF BACKGROUND DATA: MAGEC rods are increasingly used in early-onset scoliosis. Some data are available describing the structure of explanted MAGEC rods, but to date, no study has assessed their function. METHODS: Explanted MAGEC rods were received from seven UK and one Danish center. The force produced by explanted rods on activation with the external remote controller was measured using a dedicated jig. Forces were compared with two unused rods as well as the manufacturer's defined standard (42 Ibf). Clinical variables were collected from contributing centers where possible and correlated with the force measurements. RESULTS: Forty-five MAGEC rods from 25 cases were received for analysis. The mean age at insertion was 8.6 years and rods were in vivo for a mean of 2.7 years in predominantly dual rod constructs. Two unused MAGEC rods produced a mean force of 45.3 (0.25) and 50.2 (1.4) Ibf, above the manufacturer's stated standard. Of the 45 explanted rods, 10 (22%) produced force greater or equal to manufacturer's standard, mean 46.7 (2.7) Ibf. Six rods (13%) produced some force but less than the manufacturer's standard, mean 34.8 (3.6) Ibf. Twenty-nine rods (64%) produced no force. The duration the rods were in vivo was significantly negatively correlated with the force produced on testing (r = -0.63, P < 0.005). Of the 12 rods implanted longer than 38 months, none produced any force. CONCLUSION: This is the first study of the force, and hence likely function, of explanted MAGEC rods. The majority of explanted rods produced no force, while others produced reduced force. These findings raise questions regarding the longevity of the implant and further clinical outcome studies are recommended. LEVEL OF EVIDENCE: 4.

Analysis of Explanted Magnetically Controlled Growing Rods From Seven UK Spinal Centers.

STUDY DESIGN: Analysis of explanted MAGnetic Expansion Control (MAGEC) growing rods. OBJECTIVE: To analyze explanted MAGEC rods used in management of early onset scoliosis and identify the mode of failure in such cases. SUMMARY OF BACKGROUND DATA: Magnetically controlled growing rods are increasingly used as the option of choice for early onset scoliosis. However, being more complex than conventional growing rods they are perhaps more likely to succumb to multifarious failure modes. In addition, metallosis has been reported around failed MAGEC rods. METHODS: Explanted MAGEC rods from seven UK spinal centers were obtained for independent analysis. Thirty-four MAGEC rods, from 18 children, explanted for reasons including failure of rod lengthening and maximum rod distraction reached, were cut open to allow internal components to be evaluated and assessed. RESULTS: Externally, all MAGEC rods showed localized marks, which were termed "growth marks" as they indicated growth of the rod in vivo, on the extending bar component. After cutting open, titanium wear debris was found inside all 34 (100%) MAGEC rods. Ninety-one percent (31/34) of MAGEC rods showed measurable wear of the extending bar, towards the magnet end. Substantial damage to the radial bearing was seen inside 74% (25/34) of MAGEC rods while O-ring seal failure was seen in 53% (18/34) of cases. In 44% (15/34) of MAGEC rods the drive pin was fractured but this was felt to be an effect of rod failure, not a cause. CONCLUSION: The combination of high volumes of titanium wear debris alongside O-ring seal damage likely accounts for the metallosis reported clinically around some MAGEC rods. Based on this explant data, a failure mechanism in MAGEC rods due to the natural off axis loading in the spine was proposed. This is the largest data set reporting a complete analysis of explanted MAGEC rods to date. LEVEL OF EVIDENCE: 4.