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

Model Number	MS1-4590S
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned and is pending evaluation.The root cause cannot be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that a revision procedure was performed due to the rod malfunctioning and failing to continue extending.Upon removal, the extender was found to be pistoning and there were extremely deep cuts from the pistoning compared to expected normal wear and tear.The rod was additionally reported to have released a large amount of black discharge leading to a large amount of black tissue.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Additional data: b5, h3, h6, h10 device evaluation: an initial visual inspection of the returned device revealed some scoring on the distraction rod, but no deep cuts were observed.The housing tube appeared to have some rust coloring.A review of the provided photo images visually confirmed the blackening of the tissue.There was no ¿pistoning¿ observed prior to functional testing.A functional test was attempted and confirmed the reported failure to distract.During testing the device did not move with either the fast distractor, distraction test fixture or external remote controller (erc).The in-house device x-ray revealed that the bearing broke in two pieces.The rod was sectioned on the lathe and the internal components were inspected.Titanium (ti) debris was discovered on multiple components.The bearing was also visually confirmed to be broken with titanium debris covering the magnet.It is likely that the bearing was bound up by the titanium debris.This debris increased the friction inside of the bearing and some axial loading that likely generated the debris contributed to the bearing breaking.The axial loading was likely related to patient-related factors.Device record review: a review of the device history record (dhr) indicates the device was manufactured by the specified requirement at the time and met all of the required inspections before shipment.

• 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: 17782957
• Report Number: 3006179046-2023-00341
• Device Sequence Number: 5492541
• Product Code: PGN
• UDI-Device Identifier: 00812258026295
• UDI-Public: 812258026295
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• 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): 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MS1-4590S
• Device Lot Number: 0030605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2023
• 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: 08/31/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose