BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED SCREW 2.7

    MDR report key: 2630969 · Received June 25, 2012

    Report

    Report Number
    8043862-2012-00004
    Event Type
    Malfunction
    Date Received
    June 25, 2012
    Date of Event
    April 4, 2009
    Report Date
    June 21, 2012
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HWC
    PMA / PMN Number
    K080101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE THIRD COMPLAINT IN A SHORT TIMEFRAME THAT OCCURRED DURING SURGERY DONE BY THE SAME DOCTOR. THE DAMAGE SCENARIO LOOKS NEARLY THE SAME LIKE THE TWO INCIDENTS REPORTED TO AAP ONE MONTH BEFORE. THEREFORE, AAP ASSUMES A USER FAULT AND WHICH OCCURRED BECAUSE OF THE APPLICATION OF THE SCREW WITHOUT PRE-DRILLING INTO THE HARD CORTICAL BONE AS RECOMMENDED BY THE SURGERY TECHNIQUE.

    Description of Event or Problem · 1

    ALLEGEDLY, AS THE DOCTOR STARTED TO SCREW THE PRODUCT IN, THE SCREW BROKE OFF AT THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED SCREW 2.7 BONE SCREW HWC AAP IMPLANTATE AG SCN272832 W003

    Patients

    Seq Age Sex Outcome Treatment
    1