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

Model Number	MS1-4590S
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation.Evaluation was performed by (b)(6).
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2018 for an unknown reason.During a review of investigation findings from (b)(6) it was identified that the rod failed to distract.No other information in relation to patient has been reported.

• 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; suite 100; aliso viejo CA 92656
• MDR Report Key: 9951930
• Report Number: 3006179046-2020-00247
• Device Sequence Number: 2900696
• Product Code: PGN
• UDI-Device Identifier: 00812258026295
• UDI-Public: 812258026295
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/12/2020

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: MS1-4590S
• Device Lot Number: A150415-13
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 04/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 11 YR