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

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.

Event Description

Information was received that a revision procedure was performed due to the rod fracturing at the welded junction shortly after being implanted.There was no additional information provided.

Manufacturer Narrative

Additional data: b5, h6, h10.The magec rod has not been returned for an in-person evaluation.This investigation has been conducted based on provided x-ray images of the rod.The image reveals a broken rod and confirms the rod has been broken at the welded junction on the housing tube.The inspection data was reviewed and it has been confirmed that the parts met design specifications per the engineering drawings.Additionally, the work order has been reviewed and confirms the device passed all inspections per the acceptance tests which indicates the rod was manufactured by the specified requirements at that time and met all the required quality inspections prior to shipment.The exact cause of the reported failure could not be determined due to no device return/insufficient information.A review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.

Event Description

The rod has been explanted and replaced on an unknown date without further incident.The surgeon reported that there were no accidents or traumatic events that could have been responsible for the breakage.

• 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: 15887102
• MDR Text Key: 304881783
• Report Number: 3006179046-2022-00278
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002190
• UDI-Public: 856719002190
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K201543
• 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: 12/30/2022

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: RA002-5555SL
• Device Lot Number: 2020713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 12/28/2022
• Supplement Dates FDA Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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 Sex: Prefer Not To Disclose