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

Model Number RA002-4545SL70

Device Problem Mechanical Jam (2983)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation.Evaluation was performed by (b)(6).If additional relevant information is obtained, then a follow-up mdr will be submitted.

Event Description

It was reported that a revision procedure was performed due to end of growth.During a review of investigation findings from lirc it was identified that the rod had evidence galling.Additionally it was reported that the rod was unable to be retracted.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM-MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise #100; aliso viejo 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise #100; aliso viejo 92656 ; 8583448112
• MDR Report Key: 12136536
• MDR Text Key: 260528712
• Report Number: 3006179046-2021-00379
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002244
• UDI-Public: 856719002244
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RA002-4545SL70
• Device Lot Number: A140425-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1