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

Model Number	MS1-4590R
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation as the event occurred intra-operative.No root cause can be confirmed at this time.
Event or Problem Description
Information was received that during implantation the rod jammed and would not distract.
Additional Manufacturer Narrative
The rod was received for functional and visual testing.The reported failure mode was unable to be confirmed as the rod was fully functional and met acceptance test specifications.The root cause of the customer¿s report that the rod jammed and would not distract was not determined.Review of the device history record for the rods confirmed that they met all of the required quality inspections.Complaint records show similar failures reported in the past.
Event or Problem Description
See updated information in h2, h3, h6 and h10.

• 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: 9938544
• Report Number: 3006179046-2020-00165
• Device Sequence Number: 13628665
• Product Code: PGN
• UDI-Device Identifier: 00812258026301
• UDI-Public: 812258026301
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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: MS1-4590R
• Device Lot Number: A170112-02
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1