BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED SCREW 2.7X28MM

    MDR report key: 2631129 · Received June 25, 2012

    Report

    Report Number
    8043862-2012-00002
    Event Type
    Malfunction
    Date Received
    June 25, 2012
    Date of Event
    February 16, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADDITIONAL INFO RECEIVED BY THE DISTRIBUTOR OF AAP'S CANNULATED SCREWS (B)(4) STATES THAT THE SURGEON DID NOT PRE DRILL BEFORE INSERTING THE SCREW. ALTHOUGH THE SCREWS ARE SELF DRILLING AND SELF TAPPING IT IS EXPLICITLY EXPLAINED IN THE SURGERY TECHNIQUE THAT PRE-DRILLING IS RECOMMENDED IN CASE OF HARD BONE STRUCTURE TO PREVENT A DAMAGE OF THE SCREW. THE VISUAL INSPECTION OF THE SCREW SHOWS A DEFECT OF THE TIP WHICH IS A RESULT OF DRILLING THE SCREW INTO THE HARD CORTICAL BONE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED SCREW 2.7X28MM BONE SCREW HWC AAP IMPLANTATE AG SCN272832 W001

    Patients

    Seq Age Sex Outcome Treatment
    1