BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW CANC FTH 4.0 X 32MM

    MDR report key: 1842478 · Received September 17, 2010

    Report

    Report Number
    1818910-2010-06869
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWC
    PMA / PMN Number
    K903810
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE NOT PROVIDED. PROVIDED INFORMATION STATES THE PATIENT WAS SUSPECTED OF HAVING AN INFECTION DUE TO ESCHAR SCABS. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS SUSPECTED INFECTION DUE TO ESCHAR-SCABS AND WOUND NOT HEAL, AS WELL AS PAIN. THE FRACTURE HAS NOT FUSED, SO THE PLATES AND SCREWS WERE REMOVED AND AN EXTERNAL FIXATION WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW CANC FTH 4.0 X 32MM 87HWC HWC DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention