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

Model Number	MC2-4570S
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem Description
No additional information was provided.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Common Device Name: 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
• Report Number: 3006179046-2021-00440
• Device Sequence Number: 4301162
• Product Code: PGN
• UDI-Device Identifier: 00812258022600
• UDI-Public: 812258022600
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Female