BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GO-EZ SCREW

    MDR report key: 16025139 · Received December 21, 2022

    Report

    Report Number
    1832656-2022-00001
    Event Type
    Injury
    Date Received
    December 21, 2022
    Report Date
    December 15, 2022
    Manufacturer
    BIOPRO, INC
    Product Code
    HWC
    PMA / PMN Number
    K081149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    BIOPRO BECAME AWARE OF 2 GO-EZ SCREWS WHICH FAILED AT SOME POINT AFTER IMPLANTATION. AT THIS TIME WE HAVE NOT BEEN ABLE TO OBTAIN ITEM OR LOT NUMBERS TO BE ABLE TO CONDUCT A REVIEW OF THE MANUFACTURING RECORDS. AT THIS TIME THE SCREWS HAVE NOT BEEN REMOVED FROM THE PATIENT SO AN INVESTIGATION CANNOT BE CONDUCTED. AS MORE INFORMATION BECOMES AVAILABLE THIS MDR WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2918417 GO-EZ SCREW CANNULATED BONE SCREWS HWC BIOPRO, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention