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

Model Number MS1-4590S

Device Problems Corroded (1131); Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for investigation.Root cause is unavailable at this time.

Event Description

Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter, the rods were corroded and would not lengthen.There was no patient injury reported.

Manufacturer Narrative

Correction: d.4 (model number, udi number).Additional information: a.3, a.4, d.4 (lot number, expiration date), d.6, d.9, h.3, h.4, h.6, h.10.The reported failure mode was confirmed.The rod was unable to distract with manual distractor & erc.Due to the current condition of the rod (jammed), force testing was not performed.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.The cause of the jam cannot be definitively determined but may have been the bending force applied on the rods during the distraction sessions.Additionally, the patient¿s daily activities and unique anatomical structure can influence the amount of force applied to the rod.Review of the device history records 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

No additional event information has been provided.

• 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 dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 10557801
• MDR Text Key: 207697625
• Report Number: 3006179046-2020-00393
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258026349
• UDI-Public: 812258026349
• Combination Product (y/n): N
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: MS1-4590S
• Device Lot Number: A160930-02-0AC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 40