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

Model Number	MS1-5590S
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that the rod has not lengthened at all since implantation.The surgeon's course of action is unknown at this time.No patient adverse event was reported.
Additional Manufacturer Narrative
The device has not been returned for evaluation as it remains ins-situ.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Additional Manufacturer Narrative
The rod was not returned for investigation and remains in-situ.During evaluation of the provided x-ray images, it was observed that the rod has not lengthened at all, which confirmed the reported failure mode.The exact root cause of the failure could not be determined due to no device return and no indication of specific failure within the x-ray images.Based on confirmed failure mode and previous similar complaints, it is possible bending forces applied to the rod from patient anatomy/activity may have caused the distraction rod to wedge into the housing tube, which could then cause the rod to become jammed.Based on the complaint description, the surgeon's course of action is unknown at this time.Review of the device history records indicated the unit met all quality specifications and testing prior to product release.If additional information becomes available, a supplemental report will be submitted.H3 other text: x-ray analysis only.
Event or Problem Description
No additional event information was provided.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Common Device Name: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise #100; aliso viejo, CA 92656
• MDR Report Key: 14137614
• Report Number: 3006179046-2022-00177
• Device Sequence Number: 3986439
• Product Code: PGN
• UDI-Device Identifier: 00812258026318
• UDI-Public: 812258026318
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2022

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: MS1-5590S
• Device Lot Number: 0032509AAB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 41 KG