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

Model Number MS1-5590S

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

No product has been returned for evaluation nor were x-rays or ultrasound images provided to confirm the alleged event.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 reporter, the surgeon observed loose screws (unknown product) at the lower end of the construct and decided to revise the patient.

Manufacturer Narrative

Investigation findings: the rod was received for visual inspection as the device was not returned for a mechanical issue.Visual inspection revealed that the returned rod was partially distracted with score marks due to incremental distraction.There was also debris on the distraction rod, which confirmed the reported failure mode.Review of the device history record revealed no discrepancies when the rod was manufactured.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: 9474916
• MDR Text Key: 174269967
• Report Number: 3006179046-2019-00182
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258026318
• UDI-Public: 812258026318
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MS1-5590S
• Device Catalogue Number: PA0518
• Device Lot Number: A171221-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 03/25/2020
• Supplement Dates FDA Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 6 YR