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

Model Number MS1-5590S

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

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

Manufacturer Narrative

A visual inspection of the returned device revealed that one of the rodsd was confirmed to be separated at the solid section portion of the end cap.A rod was observed next to the location of the break indicating to be at the location of the fixations screw.The additional rod was observed to be partially distracted with score marks on the distraction rod.Functional testing revealed that the rod could be distracted and retracted using the manual distractor and the erc.A device history record review revealed that the magec rod met all the required quality inspections and was released within specifications.It was confirmed that the unit was unable to distract due to the patients anatomy.

• 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: 7963226
• MDR Text Key: 123669621
• Report Number: 3006179046-2018-00063
• 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: 09/14/2018

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: MS1-5590S
• Device Catalogue Number: PA0518
• Device Lot Number: A170717-07
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/12/2018
• Supplement Dates Manufacturer Received: 09/14/2018
• Supplement Dates FDA Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 16 YR