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

Model Number RA002-5555SLR

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 01/06/2017

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation.Evaluation was performed by (b)(4).

Event Description

Information was received that a revision procedure was performed on (b)(6) 2017 for an unknown.As per the reporter during service it was identified that there was clinical cold welding and debris in the housing tube.

Event Description

Information was received that a revision procedure was performed on (b)(6), 2017 for an unknown reason.During a review of investigation findings from lirc it was identified that the rod had a pin failure.No other information in relation to patient has been reported.

Event Description

Information was received that a revision procedure was performed on (b)(6) 2017 for an unknown reason.During a review of investigation findings from lirc it was identified that the rod had a pin failure.No other information in relation to patient has been reported.

• 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: 9951912
• MDR Text Key: 188743714
• Report Number: 3006179046-2020-00242
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002114
• UDI-Public: 856719002114
• Combination Product (y/n): N
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: RA002-5555SLR
• Device Lot Number: A130404-04
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 04/12/2020
• Supplement Dates Manufacturer Received: 04/23/2020; 10/23/2020
• Supplement Dates FDA Received: 04/23/2020; 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention