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

Model Number RA002-4545SL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fluid Discharge (2686)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.Root cause is unable to be determined at this time.

Event Description

Information was received that during a revision procedure for a rod exchange on an unknown date, a green/yellow fluid was seen at the actuator.No patient injury was reported.

Manufacturer Narrative

The rod was received for visual and functional testing.Visual inspection of the rod revealed score marks and debris consistent with incremental distraction.Functional testing was not applicable as the reported failure mode was that there was a green/yellow fluid.The complaint was not confirmed.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.

• 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: 10956337
• MDR Text Key: 219867083
• Report Number: 3006179046-2020-00491
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002183
• UDI-Public: 856719002183
• Combination Product (y/n): N
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

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: RA002-4545SL
• Device Lot Number: A161220-37
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/06/2020
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization