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

Model Number RA002-4545SLR, RA002-4545SL

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

It was alleged that the offset rod (ra002-4545slr, lot# a140313-02; manufacture date 03/01/2014, expiration date 03/01/2016) separated.The standard rod (ra002-4545sl, lot# a140313-18; manufacture date 03/01/2014, expiration date 03/01/2016) was fully functional.Both rods were removed and the patient was implanted with a new dual magec rods without further incident.To date, the patient is doing fine and no negative outcomes have been reported.To date, the devices have not been returned; therefore, no evaluation can be conducted.A dhr review revealed that the devices met all of the required quality inspections and were released within specifications.

Event Description

A distributor reported that a surgeon alleged that one of a patient's dual magec rods appear to not be distracting and separated at the solid section near the end cap portion of the rod after almost two (2) years of implantation.

Manufacturer Narrative

(b)(4).

• 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: 6424425
• MDR Text Key: 70622796
• Report Number: 3006179046-2017-00007
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 01/08/2017

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 Model Number: RA002-4545SLR, RA002-4545SL
• Device Lot Number: A140313-02, A140313-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2017
• Initial Date FDA Received: 03/22/2017
• Supplement Dates Manufacturer Received: 01/08/2017
• Supplement Dates FDA Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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 Weight: 35