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

Model Number RA002-5555SL

Device Problem Device Operational Issue (2914)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

It was alleged that the right side standard rod was not distracting.The standard rod was removed and was able to be distracted when tested with an erc unit after explanting the device.The device was implanted back into the patient; however was still unable to distract.The device was removed and the patient was implanted with a new magec rod without incident.To date, the patient is doing fine no negative outcomes have been reported.To date, the device has not been returned; therefore, no evaluation can be conducted.A review of the lot history revealed that the device met all of the required quality inspections and was released within specifications.

Event Description

A distributor reported that a surgeon alleged that one of a patient's dual magec rods appeared to not be distracting after approximately one (1) year of implantation.

Manufacturer Narrative

A visual inspection of the returned rod revealed it was bent, and partially distracted with score marks on the distraction rod.The unit was able to be distracted and retracted with the manual distractor and the erc.Internal inspection of the rod revealed no internal damage.The unit was determined to be fully functional.A review of the lot history record for the device revealed that the device met all of the required quality inspections and that the products were released within specifications.

• 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: 6151293
• MDR Text Key: 61698026
• Report Number: 3006179046-2016-00042
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/16/2016

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: 06/01/2016
• Device Model Number: RA002-5555SL
• Device Lot Number: A140626-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 12/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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): Hospitalization
• Patient Age: 11 YR
• Patient Weight: 26