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

Model Number MS1-5590S, MS1-5590R

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The patient was implanted with dual magec rods (ms1-5590s, lot# a120521-09-10-01u and ms1-5590r, lot# a140807-04-00-01u) on (b)(6) 2014, and it was alleged that during the first two (2) distraction sessions, the rods appeared to not be distracting; however, both rods distracted and functioned as expected when tested prior to implantation.Both rods were removed on (b)(6) 2016; the patient underwent a final fusion procedure, and was not implanted with new rods.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 distributor reported that a surgeon alleged that during the first two (2) distraction sessions, a patient's dual magec rods appeared to not be distracting.

• 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: 5820403
• MDR Text Key: 50390513
• Report Number: 3006179046-2016-00024
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/28/2016

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: 01/02/2015
• Device Model Number: MS1-5590S, MS1-5590R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2016
• Initial Date FDA Received: 07/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2013
• 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: 10 YR