BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ALPS METACARPAL HAND/FOOT PLATES

    MDR report key: 2163221 · Received July 8, 2011

    Report

    Report Number
    1818910-2011-12213
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    HRS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE UNAVAILABLE. 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 TO ADDRESS POSSIBLE INFECTION. LOOSENING OF THE PLATES WAS ALSO REPORTED. QTY: 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ALPS METACARPAL HAND/FOOT PLATES TRAUMA DEVICE HRS DEPUY ACE S.A. 'R.L. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention