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

Model Number MS1-4590S

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 11/25/2019

Event Type  Injury  

Manufacturer Narrative

No product has been returned for investigation nor were x-rays or ultrasound images provided to confirm the alleged event.It is unknown if patient complied with post-operative physical restrictions.No root cause can be confirmed at this time.

Event Description

Information was received that a revision procedure was performed on (b)(6) 2019.As per the reporter the patient had a broken rod.

Manufacturer Narrative

Investigation findings: product was returned and visual inspection was performed, customers alleged event was confirmed.Based on the investigation findings bending forces applied to the rod from patient¿s anatomy/activity may have caused the distraction rod to wedge into the housing tube and caused wear and tear, which would cause the rod to be jammed.Review of the device history record revealed no discrepancies related to this complaint.The rod was manufactured in accordance with the specified requirements and met all of the required quality inspections.

Event Description

This report has been updated to include investigation findings.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM-MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• MDR Report Key: 9506953
• MDR Text Key: 174270085
• Report Number: 3006179046-2019-00186
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258026295
• UDI-Public: 812258026295
• Combination Product (y/n): N
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MS1-4590S
• Device Catalogue Number: PA0516
• Device Lot Number: 8161028-02
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR
• Patient Weight: 32