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

Model Number MC2-4590S

Device Problem Device Operates Differently Than Expected (2913)

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 explanted the magec rods without incident.

Manufacturer Narrative

Rod 1, lot 140922-10: a visual inspection of the returned rod revealed it was partially distracted with score marks on the distraction rod.Functional testing with the manual distractor and erc revealed that the rod was unable to distract or retract.Excessive force was used to remove the distraction rod and it was confirmed the unit to have a broken locking pin.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.Rod 2, 150930-08: a visual inspection of the returned rod revealed it was partially distracted with score marks on the distraction rod.Functional testing with the manual distractor was unable to distract, however with the erc unit the rod was able to distract.The distraction force was found to be within specification, and the rod was confirmed to be functioning as intended.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: 7607370
• MDR Text Key: 111302869
• Report Number: 3006179046-2018-00045
• 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: 05/17/2018

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: Physician
• Device Model Number: MC2-4590S
• Device Catalogue Number: PA0684-001
• Device Lot Number: A140922-10, A150930-08
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/15/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 10 YR