BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM CORT LOCK SCRW 12MM

    MDR report key: 1842446 · Received September 17, 2010

    Report

    Report Number
    1818910-2010-06873
    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
    HRS
    PMA / PMN Number
    K082300
    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 PT 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 REC'D TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS SUSPECTED INFECTION DUE TO ESCHAR-SCABS AND WOULD 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 3.5MM CORT LOCK SCRW 12MM 87HRS HRS DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention