MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MAGEC GENERATION 1.5 SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM - MAGNETIC ACTUATION

Model Number	RA002-5555SL
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation as it remains in-situ.A revision surgery is reportedly being planned for december 2023.The root cause is unable to be determined at this time.D4, h4: the following potential lot numbers were provided; however, it is unknown which lot number corresponds to the rod in question: 0110922aab (manufactured 09 nov 2020) or 0101906aab (manufactured 19 oct 2020).A review of the device history records (dhr) for both potential lot numbers confirmed the device met all quality inspections and specifications prior to release.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that the rod is not distracting.A revision procedure is planned but not yet performed.There was no further patient impact reported.No additional information has been provided.
Additional Manufacturer Narrative
Additional data: b1, b2, b5, d6b, h1, h6 (health effect - impact code), h10.
Event or Problem Description
Information was received that the rod has been explanted.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Additional data: d4 (lot number), h6 (component codes, type of investigation, and investigation findings).Device evaluation: the rod was returned to nuvasive for evaluation.Upon receipt of the device, visual inspection was conducted and score marks were observed on the distraction rod which is typically associated with periodic distraction.Minor scratches were also observed along the body of the device.Device x-rays were then taken and there were no broken internal components observed.The rod was functionally tested and was unable to distract, therefore, the reported failure was confirmed.The device was then sectioned and the o-ring was found to be torn.This torn o-ring could have been caused by the force that created the score marks.Based on the marks on the distraction rod, the rod was clearly rubbing up against the housing tube.The exact root cause is unknown, however, excessive drag on the distraction rod can be caused by over-compression of the seal by the housing tube, which was clearly observed with the torn o-ring.It is most likely the rod failed to distract due to the friction forces encountered by the distraction rod and housing tube.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
The rod was sectioned and force was needed to be applied to slide the housing tube from the distraction rod.Also, the bearing was not smooth when turning it one revolution by hand.Sectioning also revealed a significant amount of black debris, likely titanium, in the housing body and around the o-ring groove.The o-ring was also observed damaged/torn and one side of the rod was shinier than the other as the anodization was rubbing off.A closer look at the rod¿s anti-rotation tabs found one was completely worn.The root cause of the failure to distract event is unable to be determined, however, it is likely that the debris found surrounding the bearing would have made it difficult to rotate.When it is coupled with the debris in the housing tube causing frictional forces between the two sliding surfaces of the rod, it would allow for the housing tube to impede distraction.

• Brand Name: MAGEC GENERATION 1.5 SPINAL BRACING AND DISTRACTION SYSTEM
• Common Device Name: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr. ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr. ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr. ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 18142222
• Report Number: 3006179046-2023-00356
• Device Sequence Number: 15069681
• Product Code: PGN
• UDI-Device Identifier: 00856719002190
• UDI-Public: 856719002190
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RA002-5555SL
• Device Lot Number: 0101906AAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 12/18/2023; 01/25/2024; 02/01/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/20/2023; 01/29/2024; 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 YR
• Patient Sex: Female