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

Model Number MS1-4590S

Device Problem Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was alleged that the patient's magec rods would not distract.The physician revised the rods with new magec rods without incident.

Manufacturer Narrative

A visual inspection of the returned devices revealed both rods were observed to be fully distracted with score marks on the distraction rod.Functional testing revealed one of the rods could be lengthened by hand when pulling on the distraction rod, which confirms a pin failure.The additional rod was found to be functional as it would distract with the manual distractor and erc.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
• MDR Report Key: 7881910
• MDR Text Key: 120444559
• Report Number: 3006179046-2018-00054
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• PMA/PMN Number: K140613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/20/2018

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: Health Professional
• Device Model Number: MS1-4590S
• Device Catalogue Number: PA0516
• Device Lot Number: A150128-10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 09/17/2018
• Supplement Dates Manufacturer Received: 07/20/2018
• Supplement Dates FDA Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 14 YR