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 Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

It was alleged that the patients right rod was damaged.The physician revised the magec rod with a new one without incident.

Event Description

It was alleged that the patient's magec rods are damaged.The physician revised the rods with new magec rods without incident.

Manufacturer Narrative

A visual inspection of the returned devices revealed to be partially distracted with score marks on the distraction rod.Both rods could be lengthened by hand when pulling on the distraction rod, which confirms the pin failures.A device history record review revealed that the magec rod met all the required quality inspections and was 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: 7878825
• MDR Text Key: 120380059
• Report Number: 3006179046-2018-00058
• 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: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• 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: A141028-01, A141014-15
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 12 YR