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

Model Number	MC2-5590S
Medical Device Problem Codes	Corroded (1131); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that the magnet appeared to be fractured internally and disassociated.Additionally, it was reported that fretting/corrosion is visible.No patient adverse event was reported.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned rod showed that the rod did not appear to be broken, however, the rod was fully distracted with score marks and debris on the distraction rod.The rod was decontaminated and some debris and yellowish color disappeared.The root cause of the score marks and debris are likely due to normal wear and tear between the distraction rod and the housing tube during the distraction sessions.Functional testing was not applicable.Based on this investigation, the reported failure could not be confirmed.Device history record review: review of device history records reveal that the rod was visually inspected and functionally tested prior to release.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Corrected information: h6 investigation findings and investigation conclusions device evaluation: visual inspection of the returned rod revealed no damage to the rod; however, the rod was fully distracted with score marks and wear consistent with incremental distraction.The fretting/corrosion that was reported was not confirmed as product was decontaminated and there was no visible corrosion.Based off the reported failure mode, there was no product failure.
Event or Problem Description
No additional information provided.
Additional Manufacturer Narrative
Corrected device evaluation: upon return, visual inspection of the magec rod showed the rod did not appear to be broken.The rod was fully distracted with score marks and debris and a yellowish color on the distraction rod.The debris and yellowish color on the rod disappeared after decontamination.Decontamination and cleaning of the rod cannot remove corrosion or fretting from the rod, therefore, the reported fretting/corrosion was unable to be confirmed.The root cause of the score marks and debris is likely due to normal usage of the rod while being implanted in the patient.X-ray images showed the magnet was seated properly in the housing body so the reported magnet fracture and disassociation were unable to be confirmed.An alternative observation found that the distraction rod is bent and out of alignment with the housing tube.X-ray images of the internal components revealed a broken radial ball bearing and locking pin.The rod was functionally tested and could not distract and retract with the external remote controller (erc) or the manual distractor.Based off of the evidence, it can be concluded that the rod was subjected to bending loads due to the patient's unique anatomical structure and daily activities that resulted in multiple issues with the rod (distraction rod bent, broken ball bearing and locking pin).As part of the investigation, the work order was reviewed and confirmed the device passed all inspections per the acceptance tests.
Event or Problem Description
No additional information has been 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; ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr; ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr; ste 100; aliso viejo, CA 92656
• MDR Report Key: 12446879
• Report Number: 3006179046-2021-00456
• Device Sequence Number: 14365412
• Product Code: PGN
• UDI-Device Identifier: 00812258022662
• UDI-Public: 812258022662
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/16/2022

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: MC2-5590S
• Device Lot Number: A14031317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• 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: 08/13/2021
• Supplement Date Received by Manufacturer: 01/31/2022; 01/31/2022; 03/11/2022
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 02/03/2022; 02/07/2022; 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2014
• 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: 17 YR
• Patient Sex: Female
• Patient Weight: 98 KG