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

Model Number	MS1-5590S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is currently in progress; a supplemental report will be submitted upon the completion of the investigation.
Event or Problem Description
Information was received that a revision procedure was performed in (b)(6) 2021 due to pin breakage and dislodgement, causing the rod not to function properly.No additional information is available.
Additional Manufacturer Narrative
No device evaluation can be performed as it is impossible to track the device.Clinical x-rays were provided by the customer which indicated a broken pin in the rod.Device history review (dhr) was performed on lot number: a141007-21 and there were no deviations in the manufacturing process and the finished product met all acceptance criteria prior to shipment.
Event or Problem Description
No new information provided.

• 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: 11613812
• Report Number: 3006179046-2021-00219
• Device Sequence Number: 19607919
• Product Code: PGN
• UDI-Device Identifier: 00812258026318
• UDI-Public: 812258026318
• 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: 2015
• Device Explanted Year: 2021
• 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): 06/21/2021

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: MS1-5590S
• Device Lot Number: A141007-21
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 06/21/2021
• 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; Required Intervention
• Patient Age: 13 YR
• Patient Weight: 45