MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED MAGEC® SYSTEM; GROWING ROD SYSTEM- MAGNETIC ACTUATION

Model Number RA002-5555SL

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 05/20/2018

Event Type  Injury  

Manufacturer Narrative

No product has been returned for evaluation.Evaluation was performed by london implant retrieval center (lric).

Event Description

Information was received that a revision procedure was performed on (b)(6) 2018 for an unknown reason.As per the reporter during service it was identified that there was a pin fracture and debris found in the housing tube.

Manufacturer Narrative

Updated the initial reporter hospital and country as there was no hospital reported.Corrected the name of the facility that the device was returned.

• Brand Name: MAGEC® SYSTEM
• Type of Device: GROWING ROD SYSTEM- MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise; suite 100; aliso viejo CA 92656
• MDR Report Key: 9951851
• MDR Text Key: 188744320
• Report Number: 3006179046-2020-00223
• Device Sequence Number: 1
• Product Code: PGN
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2020
• 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: A141222-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention