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

Model Number RA002-5555SLR

Device Problems Break (1069); Failure to Advance (2524)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation as it remains in-situ.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 Description

Information was received that x-rays taken revealed a pin break and the rod is not extracting.The rod remains implanted at this time.No additional information has been provided.

Manufacturer Narrative

Additional data: b5.H6, h10.Device evaluation: the device was not returned to nuvasive for an in-person evaluation as it remains implanted.This investigation has been conducted based on the provided x-ray images of the patient¿s body.The x-ray image revealed a broken locking pin which confirmed the reported event.A rod with a broken pin will not transfer torque from the magnet module to the lead screw which would not allow distraction.The inspection data for the lot of locking pin was reviewed and confirmed the part met design specifications per the engineering drawings.As part of the investigation the work order was reviewed and confirmed the device passed all inspections per the acceptance tests prior to shipment.Without the return of the device the exact root cause is unable to be determined, however, based on previous complaint history data, the cause of the confirmed failure may likely have been due to excessive axial loading applied on the rod during the treatment due.The patient¿s daily activities and unique anatomical structure may influence the amount of force applied to the rod.

Event Description

No additional information has been provided.

• Brand Name: MAGEC GENERATION 1.5 SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: 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: 15747398
• MDR Text Key: 304881529
• Report Number: 3006179046-2022-00271
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002114
• UDI-Public: 856719002114
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

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
• Device Operator: Health Professional
• Device Model Number: RA002-5555SLR
• Device Lot Number: 9010401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/07/2022
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Sex: Male
• Patient Weight: 33 KG