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 Unspecified Infection (1930)

Event Date 09/29/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received that a revision procedure was performed on (b)(6) 2016.As per the reporter the patient developed an infection after 24 months of device implantation.During service it was identified that there was clinical cold welding between the housing tube and distraction rod and a large amount of debris in the housing tube.

• 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
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise; suite 100; aliso viejo CA 92656
• Manufacturer Contact: tiara rae ; 101 enterprise; suite 100; aliso viejo, CA 92656
• MDR Report Key: 9951879
• MDR Text Key: 188744348
• Report Number: 3006179046-2020-00231
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002114
• UDI-Public: 856719002114
• 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: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• 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: RA002-5555SLR
• Device Lot Number: A140605-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR