BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5 LOCKING SHAFT SCREW 40MM

    MDR report key: 1152840 · Received September 5, 2008

    Report

    Report Number
    1818910-2008-03526
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    HRS
    PMA / PMN Number
    K060969
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFO PROVIDED, AS THE LOT NUMBER REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY WARSAW CONSIDERS THE INVESTIGATION CLOSED. SHOULD THE PRODUCT AND/OR ANY ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    AS THE RESULT OF AN ONGOING INFECTION, THE SURGEON ATTEMPTED TO REMOVE THE PEAK FX IMPLANT. UPON REMOVAL OF THE LAST 4.5 LOCKING CORTICAL SCREW FROM THE SIDE PLATE, THE SCREW WAS FOUND TO BE COLD-WELDED TO THE PLATE. EXTREME PRESSURE FROM THE SCREWDRIVER RESULTED IN STRIPPING THE HEAD (SCREWS HAD BEEN PUT IN BY HAND, NOT WITH POWER). THE STATE WAS NOT REMOVED BECAUSE THE HOSPITAL DID NOT HAVE THE APPROPRIATE EQUIPMENT TO EXCISE THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5 LOCKING SHAFT SCREW 40MM 87HRS HRS DEPUY ACE S.A. 'R.L. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR