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

Model Number RA002-4545SLR

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

No product has been returned for investigation nor were radiographs provided to confirm alleged event.

Event Description

It was reported offset rod was found broken in 2014.Patient underwent a revision procedure on (b)(6) 2014 where removal of the rod was performed.On (b)(6) 2018 both rods were removed to perform a regular stabilization.

Manufacturer Narrative

Rod (b)(4) was returned for evaluation and the reported issue was confirmed.Even though root cause cannot be confirmed, device jam may be related to bending forces.

Event Description

Information was received that a revision procedure was performed on (b)(6) 2014.As per the reporter, the rod was broken.

Manufacturer Narrative

The initial and device evaluation follow up reports were submitted with the incorrect model, lot and udi number and have been corrected in this report.No product has been returned for evaluation.No root cause can be confirmed at this time.

• 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: 8262929
• MDR Text Key: 133934630
• Report Number: 3006179046-2019-00100
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002183
• UDI-Public: 856719002183
• Combination Product (y/n): N
• PMA/PMN Number: K140613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RA002-4545SLR
• Device Catalogue Number: PA0237
• Device Lot Number: A120202-05
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1