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

Model Number	MC2-5070S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.Root cause is unable to be determined at this time.The reported event has been addressed in the device labeling.
Event or Problem Description
Information was received that a revision procedure was performed on an unknown date.As per the reporter, the rod was broken.Reportedly, when the rod was explanted it was noticeably broken at the part where the rod comes out when distracting.There was no patient injury reported.
Additional Manufacturer Narrative
The rod was received for visual and functional testing.Visual inspection reveal no damage.There was no breakage observed on the distraction rod or housing tube.X-ray images of the internal components revealed no damage and that the rod was partially distracted.The rod was able to distract and retract with the fast distractor.The reported failure mode was not confirmed, the rod was fully functional and met acceptance test specifications.A device history review (dhr) was performed on lot number 7092802bab and there were no deviations in the manufacturing process and the finished product met all acceptance criteria prior to shipment.

• 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: 10979216
• Report Number: 3006179046-2020-00495
• Device Sequence Number: 19898193
• Product Code: PGN
• UDI-Device Identifier: 00887517834027
• UDI-Public: 887517834027
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MC2-5070S
• Device Lot Number: 7092802
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization