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

Model Number RA002-5555SLR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

A surgeon alleged that one of a patient's magec rods appeared to not be distracting after approximately two (2) years of implantation.The patient was initially implanted with dual magec rods in 2014.It was alleged that the right side 5.5mm offset rod was not distracting; the left side standard rod was fully functional.The offset rod was removed on (b)(6) 2016; upon explantation, it was reported that tissue discoloration was observed near the actuator.The patient was implanted with a new magec rod without further incident.To date, the patient is doing fine and no negative outcomes have been reported.A dhr review revealed that there were no deviations from the manufacturing process, and the device was released within specifications.

Event Description

A representative reported that a surgeon alleged that one of a patient's dual magec rods appeared to not be distracting after approximately two (2) years of implantation.

Manufacturer Narrative

A distributor reported that a surgeon alleged that one of a patient's dual magec rods appeared to not be distracting after almost four years of implantation.

• 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
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• Manufacturer Contact: john mcintyre ; 101 enterprise; suite 100; aliso viejo, CA 92656 ; 9498373600
• MDR Report Key: 5751653
• MDR Text Key: 48247279
• Report Number: 3006179046-2016-00022
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K140178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/27/2016

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?: No
• Device Operator: Physician
• Device Expiration Date: 05/01/2014
• Device Model Number: RA002-5555SLR
• Device Lot Number: A120516-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2016
• Initial Date FDA Received: 06/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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): Hospitalization
• Patient Age: 11 YR