MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED MAGEC GENERATION 2B SPINAL BRACING AND DISTRACTION SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	MC2-5570S
Medical Device Problem Codes	Fracture (1260); Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a revision procedure was performed due to the contralateral rod failing to distract.It was noted that there was a locking pin failure as the distraction rod moves freely.
Additional Manufacturer Narrative
The product was returned to the manufacturer and the device evaluation findings are not yet available.A root cause was unable to be determined with the information provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
The device was returned for evaluation, although there was no reported failure of the rod.It was removed due to the contralateral rod failing to distract.Visual inspection of the rod was conducted, and it was observed that there was debris at the junction of the housing tube and the distraction rod.Upon physical inspection of the distraction rod, it was discovered to move freely.Scoring was observed on the distraction rod which corresponds to periodic distractions.No other markings were observed on the rod housing tube.To perform a thorough evaluation of the device, the rod was sectioned.It was observed that the lead screw had separated from the magnet assembly.The same x-rays also showed that the bearing had broken and that the retaining clip was pulled out from the clip groove.Functional testing was attempted, however, it failed to distract due to the broken pin.The complaint for locking pin failure has been confirmed.It is highly likely that the pin broke due to the bearing seizing.The x-rays clearly depict a broken bearing.As the bearing sees more friction due to internal debris, it locks up and will ultimately break if enough torque is applied.This same torque possibly was the cause of the pin break.It cannot be known, but it is possible that there was an interaction between the two rods.It is possible that if the other rod (lot 9052209) failed to distract, it may have caused the failure of this rod.A review of the dhr documents indicates the device was manufactured by the specified requirement at the time and met all the required inspections before shipment.
Event or Problem Description
No additional information was provided.

• Brand Name: MAGEC GENERATION 2B SPINAL BRACING AND DISTRACTION SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise suite 100; aliso viejo CA 92656
• Manufacturer Contact: patrick yrigoyen ; 101 enterprise suite 100; aliso viejo, CA 92656 ; 8583442667
• MDR Report Key: 19798287
• Report Number: 3006179046-2024-00143
• Device Sequence Number: 4145052
• Product Code: PGN
• UDI-Device Identifier: 00812258022648
• UDI-Public: 812258022648
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K233593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2024

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: MC2-5570S
• Device Lot Number: 9060309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2024
• 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: 06/27/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown