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 Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 10/31/2019

Event Type  Injury  

Event Description

Information was received that a revision procedure was performed on (b)(6) 2019.As per reporter, after multiple attempts to lengthen in clinic, the rod showed no sign of distraction.

Manufacturer Narrative

Investigation results: the device was received for visual and functional testing.Visual testing revealed score marks on the rod due to incremental distractions.Functional testing revealed the rod was unable to distract with manual distractor and the electronic remote controller (erc).The rod was sectioned and debris build up was found, which may have caused the reduced functionality.Sectioning of the rod determined that it could not be separated from the housing without use of high force.Bending forces applied to the rod from patient anatomy/activity may have caused the distraction rod to wedge into the housing tube, which would cause the rod to be jam.

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: 9370964
• MDR Text Key: 167979515
• Report Number: 3006179046-2019-00177
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258026325
• UDI-Public: 812258026325
• 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?: Yes
• Device Operator: Health Professional
• Device Model Number: MS1-5590S
• Device Catalogue Number: PA0518
• Device Lot Number: A140213-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 08/12/2020
• Supplement Dates FDA Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR
• Patient Weight: 31