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

Model Number RA002-5555SL

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

No product has been returned for investigation nor were x-ray films provided that confirm the alleged event.No root cause can be identified at this time.Labeling review: warning: ".Metallic implants can loosen, fracture, corrode, migrate, or cause pain." no product returned.

Event Description

As per reporter rods were no longer distracting and patient underwent a revision procedure.

Manufacturer Narrative

The rods were received for functional and visual testing and the reported event was confirmed.The root cause of the reported event may be related to bending force applied during the distraction sessions and/or patient's daily activities.

• 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: 8956962
• MDR Text Key: 156388145
• Report Number: 3006179046-2019-00151
• Device Sequence Number: 1
• Product Code: PNG
• UDI-Device Identifier: 00856719002190
• UDI-Public: 856719002190
• 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
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RA002-5555SL
• Device Lot Number: 1112158-010
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization