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

Model Number	MC2-4570R
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for investigation as it remains implanted radiographs provided confirm the alleged event.
Event or Problem Description
Information was received that x-ray images revealed that the end cap had disengaged.No revision procedure is planned as the rod is still in-situ.There was no patient injury reported.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
The product was returned and the reported failure mode was confirmed.Visual inspection of the returned products confirmed the end caps were unthreaded from the housing tubes.The returned rods were observed to be partially distracted.X-ray imaging inspection was also performed for both rods; end cap disengagements were clear.Per reported failure, functional testing and internal component inspection were not applicable.Review of the device history records indicated the rods were functionally tested.The issue recorded in this complaint is a known issue and has been investigated.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Common Device Name: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 10348385
• Report Number: 3006179046-2020-00357
• Device Sequence Number: 14184764
• Product Code: PGN
• UDI-Device Identifier: 00812258022617
• UDI-Public: 812258022617
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Notification,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2021

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
• Operator of Device: Health Professional
• Device Model Number: MC2-4570R
• Device Lot Number: 9021601AAA
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 07/01/2020; 01/27/2021
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 09/30/2020; 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1898-2020
• Patient Sequence Number: 1