BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY UNICORTICAL SCREWS

    MDR report key: 2052539 · Received April 11, 2011

    Report

    Report Number
    1818910-2011-06329
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    DEPUY CMW
    Product Code
    HWC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES AND/OR X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED FOR THE PEGS AND SCREWS WERE UNAVAILABLE. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED FOR THE PLATE WAS NOT PROVIDED. A TWO-YEAR SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY A TREND. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD 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

    PT WAS REVISED BECAUSE THE HUMERAL HEAD COLLAPSED. QTY: 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY UNICORTICAL SCREWS TRAUMA DEVICE HWC DEPUY CMW NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention