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

Model Number MS1-5590S

Device Problem Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event 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.

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.

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 Description

No additional event information was provided.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: 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
• MDR Text Key: 290114299
• Report Number: 3006179046-2022-00177
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258026318
• UDI-Public: 812258026318
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/18/2022
• Supplement Dates Manufacturer Received: 05/26/2022
• Supplement Dates FDA Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 41 KG