BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED OZARK SCREW

    MDR report key: 14643703 · Received June 9, 2022

    Report

    Report Number
    3004774118-2022-00223
    Event Type
    Malfunction
    Date Received
    June 9, 2022
    Date of Event
    January 1, 2022
    Report Date
    June 9, 2022
    Manufacturer
    K2M, INC.
    Product Code
    KWG
    PMA / PMN Number
    K172104
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REMAINS IMPLANTED AND WAS THEREFORE NOT RETURNED FOR EVALUATION. DEVICE HISTORY RECORDS AND COMPLAINT HISTORY COULD NOT BE REVIEWED WITHOUT EITHER THE DEVICE OR A VALID LOT NUMBER. LIMITED INFORMATION REGARDING THE EVENT WAS MADE AVAILABLE TO STRYKER. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED. A ROOT CAUSE CANNOT BE ESTABLISHED. IF ADDITIONAL INFORMATION IS RECEIVED OR THE DEVICE IS RETURNED FOR EVALUATION, THE INVESTIGATION WILL BE REOPENED AND UPDATED.

    Description of Event or Problem · 0

    A COMPANY REPRESENTATIVE REPORTED THAT OZARK SCREW FRACTURES WERE OBSERVED APPROXIMATELY ONE YEAR AFTER IMPLANTATION. THE CONSTRUCT SPANNED C5 TO C7; BILATERAL SCREW FRACTURES WERE NOTED AT THE CRANIAL LEVEL AND A UNILATERAL SCREW FRACTURE WAS NOTED AT THE CAUDAL LEVEL. REVISION SURGERY HAS NOT OCCURRED. THIS REPORT CAPTURES THE FIRST OF THREE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2054865 UNSPECIFIED OZARK SCREW APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWG K2M, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown