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

Model Number MC2-5090S

Device Problem Corroded (1131)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device has been received and is pending evaluation.The root cause is unable to be determined at this time.A supplemental report will be submitted upon completion of the device evaluation.

Event Description

Information was received that a revision was performed for a final fusion.As per the reporter, upon explant the rod was noted to have corrosion and there was metal wear debris in the tissue.No patient harm was reported.

Manufacturer Narrative

Device evaluation: upon return, visual inspection of the returned product revealed the distraction rod component had visible score marks and laser marks.The returned rod was observed to have been distracted.The device's work order was reviewed and confirmed the device passed all inspections per the acceptance tests which indicated the rod was manufactured by the specified requirements and met all the required quality inspections prior shipment third party evaluation: qualitative assessment of the reported corrosion damage on the implant was assessed via scanning electron microscopy and chemical energy dispersive x-ray (edx) analysis of the implant surface and debris.Despite initial indication of substantial implant corrosion and corrosion debris, there was little indication of wear/corrosion (i.E.Fretting, pitting and crevice) associated with the implant components was found.Complex carbon based deposits were observed that are heterogenous in composition.Prior to removal of this debris the piston was easily manually manipulated in the sheath (smooth movement) exposing non-carbonated virgin-like surface coated in spots with silicone-like deposits.Minor precipitates on the material surface were silicone and carbon based protein precipitates and not ti-rich deposits.This indicates a lack of mechanically assisted corrosion occurring at the implant modular connections.Device records review: review of the device history records for the rod confirmed that it met all of the required quality inspection criteria prior to release.

• 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 dr, suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr, suite 100; aliso viejo, CA 92656
• MDR Report Key: 12315505
• MDR Text Key: 266303106
• Report Number: 3006179046-2021-00442
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00887517834041
• UDI-Public: 887517834041
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 7110102AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 12/15/2021
• Supplement Dates FDA Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 55 KG