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

Model Number MC2-5090S

Device Problems Loose or Intermittent Connection (1371); Defective Component (2292)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2018

Event Type  Injury  

Manufacturer Narrative

Product has been returned and mating components were not present.A review of x-ray films provided confirm anomaly that may result in failure to distract.

Event Description

It was reported the surgeon noticed a round shape above the actuator on the distraction rod following the first lengthening 3months post-operative.As per reporter the same shape appeared on an x-ray image following the second distraction.Patient undewent a revision surgery on or approximately on (b)(6) 2018 with no reported issues.

Manufacturer Narrative

A visual inspection of the returned rods revealed one of the rods was completely disassembled.The disassembled rod was returned with the threaded cap, clip ring, and anti-jam components missing, the second rod was intact and could be distracted with the manual distractor as designed and demonstrated a satisfactory force.It was determined that the retaining ring was out of the groove based on x-ray and by measuring the backlash.The threaded cap was also able to be loosened by hand.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: 8040420
• MDR Text Key: 126664193
• Report Number: 3006179046-2018-00066
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00887517834041
• UDI-Public: 00887517834041
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC2-5090S
• Device Lot Number: 7102419
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 8 YR