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

Model Number MS1-4570S

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

It was alleged that the magec rod stopped lengthening.The physician revised the rod with a new magec rod without incident.

Manufacturer Narrative

A visual inspection of the returned device revealed it was partially distracted with score marks on the distraction rod.Functional testing revealed that the manual distractor and erc could not distract or retract the rod.Sectioning of the rod determined that the distraction rod could not be separated from the housing without use of high force.Bending forces applied to the rod from patient anatomy/activity may have caused the distraction rod to wedge into the housing tube, which would cause the failure to distract.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: 7839604
• MDR Text Key: 119019207
• Report Number: 3006179046-2018-00055
• 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: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MS1-4570S
• Device Catalogue Number: PA0561
• Device Lot Number: A151103-04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention