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

Model Number MC2-4570S

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Date 03/06/2020

Event Type  Injury  

Manufacturer Narrative

No product has been returned for evaluation nor were lab culture results provided to confirm the alleged event.No indication of product malfunction was identified.Based on the information provided root cause could not be identified.

Event Description

Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter, the patient developed an infection and the surgeon decided to remove the rod.There was no alleged device malfunction.

Manufacturer Narrative

The received rod was tested and fully functional.X-ray imaging inspection was performed which showed an end cap disengagement.Review of the device history record showed that the rod had been appropriately sterilized prior to release.Additionally, no tissue images and lab reports were provided and no issues with the functionality of the rods were reported.Thus, based on this investigation, there was no evidence provided to confirm the reported failure mode.However, during the investigation, an unreported end cap failure was observed and confirmed.Fsca investigation was performed and variation in the torque applied to the threaded cap during the assembly process was identified as the root cause of the failure.Per the manufacturing instructions, the threaded cap must be tightened to 40 in-lbs.Although all operators followed the assembly procedure, and the torque wrench indicated 40 in-lbs was applied, the manner of using the torque wrench resulted in variances in applied torque.The manner in which the operator handles the torque wrench may impact the actual torque applied to the end cap, thereby creating a false positive that the specified torque has been applied.If the specified torque is not applied, the effectiveness of the cap tightening process may be compromised.

Event Description

Additional information provided.

• 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: 9908668
• MDR Text Key: 188504138
• Report Number: 3006179046-2020-00161
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258022600
• UDI-Public: 812258022600
• 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,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MC2-4570S
• Device Lot Number: 9082102
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1898-2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other