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

Model Number RA002-5555SL70

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation.Root cause cannot be determined at this time.The reported event has been addressed in the device labeling.

Event Description

Information was received that a revision procedure was performed on an unknown date.As per the reporter, x-ray images reveal that the rod was broken in two pieces.The patient did not report any discomfort or pain during the distraction process.

Event Description

No additional information was provided.

Manufacturer Narrative

Additional data: d8, d9, h3, h4, h6, h10.Correction: h1.Device records review: review of the device history record for the rod confirmed that it met all of the required quality inspections and criteria prior to release.Device evaluation: the device was evaluated and found to be fractured.Review of the patient¿s x-ray images reveal that the rod was fully distracted.Review of the manufacturing work order confirmed the device passed all inspections per the acceptance tests.The inspection data for the lot was reviewed and confirmed the part met design specifications per the engineering drawings.A definitive cause could not be determined but the type of fracture observed can be a result of a patient¿s daily activities and/or the patient's unique anatomical structure, both of which can influence the amount of stress applied to certain sections of the rod.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 11336197
• MDR Text Key: 232587249
• Report Number: 3006179046-2021-00125
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002152
• UDI-Public: 856719002152
• Combination Product (y/n): N
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RA002-5555SL70
• Device Lot Number: A160411-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization