BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN:C2

    MDR report key: 20422879 · Received October 10, 2024

    Report

    Report Number
    3006404071-2024-00007
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Date of Event
    October 7, 2024
    Report Date
    October 10, 2024
    Manufacturer
    SPINESMITH HOLDINGS,LLC
    Product Code
    OVE
    PMA / PMN Number
    K122630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME CELLING IS PENDING THE DISPOSITION OF THE PART THAT FAILED FOR PENDING INVESTIGATION. FOLLOW UP WILL BE PROVIDED AS SOON AS INFORMATION IS GATHERED FROM INSPECTION TESTING. FOLLOW UP NOTES: DURING A SPINAL PROCEDURE THE PHYSICIAN DISCOVERED THAT A SPINAL IMPLANT HAD FAILED. THE IMPLANT HAD DISENGAGED AND NEEDED TO BE REPLACED. DR REPORTED THERE WAS NO INJURY TO THE PATIENT BUT THE SURGEON WAS ABLE TO COMPLETE THE SURGERY BY REPLACING THE IMPLANT. PART# INC2 CAGE SMALL 7MM WAS DISCARDED BY THE DR. AND THE PART WAS UNABLE TO BE EVALUATED FOR POSSIBLE CAUSE. EVALUAION OF IN-HOUSE INC2 CAGES WERE UNABLE TO DUPLICATE THE ISSUE. IT SEEMS AS THOUGH DURING MANUFACTURING THE GLUE WAS NOT ADEQUATE ON THIS PARTICULAR CAGE BUT WE CAN NOT SAY FOR SURE IF THAT IS WHAT HAPPEN HERE. REVIEW OF PAST CALLS SHOWS THAT THIS HAS NEVER HAPPENED BEFORE. WE WILL CONTINUE TO MONITOR CALLS AND PRODUCT IN ACCORDANCE WITH CUSTOMER FEEDBACK PROCEDURES ALREADY IN PLACE.

    Additional Manufacturer Narrative · 0

    AT THIS TIME CELLING IS PENDING THE DISPOSITION OF THE PART THAT FAILED FOR PENDING INVESTIGATION. FOLLOW UP WILL BE PROVIDED AS SOON AS INFORMATION IS GATHERED FROM INSPECTION TESTING.

    Description of Event or Problem · 0

    CELLING REPRESENTATIVE REPORTED THAT DURING SURGERY THE PHYSICAN REPORTED THAT WHEN IMPLANTING A IN:C2 CAGE SMALL 7MM, IT DISENGAGED AND THE DR HAD TO USE A 2ND CAGE. THERE WAS NO IMPACT TO THE PATIENT AND THE SURGERY WAS ABLE TO BE COMPLETED AS EXPECTED USING THE 2ND CAGE. NO ADDITIONAL PREVENTATIVE OR MEDIATION WAS REQUIRED. IMAGES WERE PROVIDED FOR EVALUATION. INITIAL EVALUATION BY ENGINEERING NOTED THIS TO BE A MANUFACTURING DEFECT. CELLING HAS REQUESTED THAT THE PART BE RETURNED FOR INVESTIGATION. CELLING WILL ALSO INITIATE INVESTIGATION WITH MFG OF THE FAILED PART.

    Description of Event or Problem · 0

    CELLING REPRESENTATIVE REPORTED THAT DURING SURGERY THE PHYSICIAN REPORTED THAT WHEN IMPLANTING A IN:C2 CAGE SMALL 7MM, IT DISENGAGED AND THE DR HAD TO USE A 2ND CAGE. THERE WAS NO IMPACT TO THE PATIENT AND THE SURGERY WAS ABLE TO BE COMPLETED AS EXPECTED USING THE 2ND CAGE. NO ADDITIONAL PREVENTATIVE OR MEDIATION WAS REQUIRED. IMAGES WERE PROVIDED FOR EVALUATION. INITIAL EVALUATION BY ENGINEERING NOTED THIS TO BE A MANUFACTURING DEFECT. CELLING HAS REQUESTED THAT THE PART BE RETURNED FOR INVESTIGATION. CELLING WILL ALSO INITIATE INVESTIGATION WITH MFG OF THE FAILED PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300009 IN:C2 IN:C2 CAGE 7MM OVE SPINESMITH HOLDINGS,LLC IN:C2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization