BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAND ALONE CERVICAL

    MDR report key: 13015098 · Received December 15, 2021

    Report

    Report Number
    3006494201-2021-00011
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    November 11, 2021
    Report Date
    December 15, 2021
    Manufacturer
    CORELINK, LLC
    Product Code
    OVE
    PMA / PMN Number
    K200087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A HISTORICAL REVIEW WAS CONDUCTED, AND IT WAS DETERMINED THAT THERE HAVE BEEN NO OTHER REPORTS FILED FOR THIS PART NUMBER. A REVIEW WAS CONDUCTED OF THE PRODUCTION RECORDS, AND NO INCONSISTENCIES WERE FOUND. 2020-117 WAS CONFIRMED TO BE DAMAGED RESULTING IN THE INSTRUMENT NOT BEING ABLE THREAD INTO THE SCREW HEAD DURING REMOVAL. INSPECTION SHOWS THAT THE THREADS WERE BENT AND DAMAGED RENDERING THE INSTRUMENT UNUSABLE FOR ITS INTENDED PURPOSE. THE IMPACTED THREADS ARE SMALL, SO THE DAMAGE COULD HAVE RESULTED FROM MISUSE OR NORMAL WEAR AND TEAR. THE SPECIFIC ROOT CAUSE WAS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CASE, THE INSTRUMENT WAS BEING UTILIZED TO REMOVE AN IMPLANTED SCREW. THE PHYSICIAN WAS UNABLE TO GET THE REMOVAL TOOL TO FUNCTION CORRECTLY WITH THE SCREW. APPROXIMATELY 30 MINUTES WERE ADDED TO THE CASE, AND THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911161 STAND ALONE CERVICAL REMOVAL TOOL OVE CORELINK, LLC 2020-117 SM114594

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown