BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM MULTIDIRECT SCREW 65MM

    MDR report key: 6620703 · Received June 7, 2017

    Report

    Report Number
    0001825034-2017-03674
    Event Type
    Injury
    Date Received
    June 7, 2017
    Date of Event
    January 17, 2017
    Report Date
    June 6, 2017
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HRS
    PMA / PMN Number
    PK111663
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. DATE EXPLANTED - IT IS UNKNOWN IF THE SCREW WAS REMOVED IN THE (B)(6) 2017 PROCEDURE. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2016-05039-1, 03672, 03673, 03674, 03677, 03678, 03679, AND 03680.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REMOVAL OF A RIGHT PROXIMAL TIBIAL PLATE APPROXIMATELY TWENTY-TWO MONTHS POST-IMPLANTATION, IT WAS FOUND THAT SOME OF THE SCREWS WERE STRIPPED AND SOME OF THE LOCKING SCREWS WERE COLD WELDED TO THE PLATE. ULTIMATELY, THE PLATE AND ONE SCREW WERE LEFT IMPLANTED IN THE PATIENT, AS THEY WERE UNABLE TO COMPLETE THE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400412 3.5MM MULTIDIRECT SCREW 65MM PLATE, FIXATION, BONE HRS BIOMET TRAUMA N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention