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

Model Number MC2-4570R

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

Product has been returned for investigation, once investigation has been concluded a supplemental report will be submitted.

Event Description

It was reported that a revision procedure was performed on (b)(6) 2020 as the endcap came loose on the magec-x.No patient injury was reported.

Event Description

See updated information in h2, h3, h6 and h10.

Manufacturer Narrative

The rod was received for visual and functional testing.Visual inspection revealed that the rod was partially distracted.X-ray imaging confirmed the reported issue.The end cap had disengaged.Functional testing was unable to be performed due to the condition of the nail.A device history review (dhr) was performed on lot number 8122610aaa and there were no deviations in the manufacturing process and the finished product met all acceptance criteria prior to shipment.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.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 10659675
• MDR Text Key: 210851908
• Report Number: 3006179046-2020-00408
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258022617
• UDI-Public: 812258022617
• 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: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC2-4570R
• Device Lot Number: 8122610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1898-2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization