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

Model Number MC2-4570S

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

Event Description

Information was received that a revision procedure was performed for a final fusion.As per the reporter, at the time of removal the rod was noted to have corrosion and metal wear debris was found in the tissue.No patient harm was reported.

Manufacturer Narrative

Corrected data: d4 (model number and lot number), d8, h6 (health impact and clinical codes) device evaluation: upon return, visual inspection of the returned product revealed the distraction rod component had visible discoloration at its junction with the housing tube component.The device's work order was reviewed and confirmed the device passed all inspections per the acceptance tests, which indicated the rod was manufactured per specified requirements and met all the required quality inspections prior shipment.The device was subsequently sent for third party analysis.Third party evaluation: qualitative assessment of the reported corrosion damage on the implant was assessed via scanning electron microscopy (sem) and chemical energy dispersive x-ray (edx) analysis of the implant surface and debris.Despite initial indication of substantial implant corrosion and corrosion debris, only mild evidence of wear/corrosion (i.E.Fretting, pitting and crevice) associated with the implant components was found at the junction of the distraction rod and housing tube, and no clearly identifiable wear or corrosion was observed on other areas of the implant.Instead, it was found there was appreciable deposition of biologically derived/enhanced debris and carbon-based protein precipitates (not ti-o rich deposits as would be expected with ti-alloy corrosion).In total, this indicates only a minor amount of mechanically assisted corrosion occurred at the implant modular interface.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.

Event Description

No additional information was provided.

• 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: 12315381
• MDR Text Key: 266307669
• Report Number: 3006179046-2021-00440
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258022600
• UDI-Public: 812258022600
• 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: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC2-4570S
• Device Lot Number: 9093011AAA
• 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
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2019
• 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: 14 YR
• Patient Sex: Female