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

Model Number RA002-5555SLR

Device Problem Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation.Evaluation was performed by (b)(6).If additional relevant information is obtained, then a follow-up mdr will be submitted.

Event Description

It was reported that a revision procedure was performed for an unknown reason.During a review of investigation findings from lirc it was identified that the rod had evidence of pin fracture, galling, corrosion, and a broken radial bearing.Additionally it was reported that the rod was unable to be retracted.

Event Description

Na.

Manufacturer Narrative

Additional information: no product has been returned for evaluation, however, investigation of the failure revealed that corrosion, surface finish and bending stresses all contribute to pin breaking.A new pin was implemented that had 65% improved strength and significantly improved corrosion resistance.

Event Description

N/a.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM-MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise #100; aliso viejo CA 92656
• MDR Report Key: 12125139
• MDR Text Key: 260515127
• Report Number: 3006179046-2021-00352
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002114
• UDI-Public: 856719002114
• Combination Product (y/n): N
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2021

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: A140425-16
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 06/25/2021; 07/28/2021
• Supplement Dates FDA Received: 07/07/2021; 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1