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

Model Number	MC2-6090R
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation as it remains in-situ.X-rays confirmed the alleged event.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 x-ray showed the endcap of the rod seems to be popped up (gap between actuator and end cap).It is unknown if a revision procedure is planned at this time.No patient injury has been reported.
Event or Problem Description
A revision procedure was performed on an unknown date.
Additional Manufacturer Narrative
Device records review: review of the device history records for the rod confirmed that it met all of the required quality inspections prior to release.Device evaluation: visual inspection of the returned product confirmed the threaded cap was unthreaded from the housing tube.The returned rod was observed to be partially distracted.X-ray imaging inspection was also performed and threaded cap disengagement was noted.This issue is related to field safety notice z-1898-2020.

• 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: 11033846
• Report Number: 3006179046-2020-00504
• Device Sequence Number: 1034344
• Product Code: PGN
• UDI-Device Identifier: 00812258022716
• UDI-Public: 812258022716
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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: MC2-6090R
• Device Lot Number: 8122106AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 04/29/2021
• 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
• Patient Age: 13 YR
• Patient Weight: 30