BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF-DRILLING HALF PIN APEX Ø 3MM, 110 X 25MM

    MDR report key: 2950335 · Received February 8, 2013

    Report

    Report Number
    0008031020-2013-00010
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    JDW
    PMA / PMN Number
    K86766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISCARDED. NO EVALUATION WILL BE PERFORMED. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. (B)(4): DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    THE SALES REP REPORTED, "THE SURGEON WAS PERFORMING AN EXTRACTION OF THE INTERNAL FIXATION IMPLANT DGB. DURING THE EXTRACTION AN APEX FICHE BROKE OFF. THE SURGEON DECIDED TO LEAVE THE BROKEN PART IN THE PATIENT. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54613 SELF-DRILLING HALF PIN APEX Ø 3MM, 110 X 25MM IMPLANT JDW STRYKER OSTEOSYNTHESIS-SELZACH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other