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

Model Number RA002-5555SL

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 10/30/2019

Event Type  Injury  

Manufacturer Narrative

No product has been returned for investigation nor were x-rays images provided to confirm the alleged event.No root cause can be confirmed at this time.

Event Description

Information was received that a revision procedure was performed on (b)(6) 2019.As per the reporter, the rods stopped functioning after a few distractions.

Manufacturer Narrative

The rod was received for visual and functional testing.Visual testing revealed score marks on the rod consistent with incremental distraction.Functional testing revealed the rod could be partially distracted and retracted using both the manual distractor and electronic remote controller (erc).The reported failure mode was confirmed as the rod was not fully functional and it did not meet all acceptance test specifications.Review of the device history records revealed no discrepancies related to this complaint.The rod was manufactured in accordance with the specified requirements and met all of the required quality inspections.A corrective action determined the root cause to be caused by wear between the distraction rod and the housing during distraction sessions contributing to titanium debris as a factor.

Event Description

This report has been updated to include investigation findings.

• 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; suite 100; aliso viejo CA 92656
• MDR Report Key: 9372939
• MDR Text Key: 167979868
• Report Number: 3006179046-2019-00179
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002190
• UDI-Public: 856719002190
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RA002-5555SL
• Device Catalogue Number: PA0239
• Device Lot Number: A170424-08
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention