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

Model Number	RA002-4545SLR
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that during x-ray it was discovered that the rod did not distract at all.The rod was removed and replaced with a new rod.
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.A review of the device history records (dhr) 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
No additional information has been provided.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned device does not reflect any apparent damage to the distraction rod or the housing body.Functional testing has been conducted and confirmed the reported failure of the device not distracting.The in-house device x-rays showed the distraction rod was pressed against the ball bearing and the ball bearing against the magnet; this likely caused the device to jam.The exact root cause is unable to be determined, however, it is possible that this is related to a user-error either with an external remote controller (erc).

• 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: 17451651
• Report Number: 3006179046-2023-00319
• Device Sequence Number: 7288950
• Product Code: PGN
• UDI-Device Identifier: 00856719002138
• UDI-Public: 856719002138
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K201543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 10/27/2023

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: RA002-4545SLR
• Device Lot Number: 0111608AAB
• 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: 07/26/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2020
• 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
• Patient Age: 9 YR
• Patient Sex: Female
• Patient Weight: 14 KG