BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DVR ANATOMIC WIDE LEFT

    MDR report key: 2023535 · Received March 3, 2011

    Report

    Report Number
    1818910-2011-03528
    Event Type
    Malfunction
    Date Received
    March 3, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 7, 2011
    Manufacturer
    DEPUY ACE S.A. `R.L.
    Product Code
    LXT
    PMA / PMN Number
    K050932
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED WAS NOT PROVIDED. 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

    WHILE PLATING OF LEFT DISTAL RADIUS, THE SURGEON LEFT A FAST GUIDE TAB IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DVR ANATOMIC WIDE LEFT 87LXT LXT DEPUY ACE S.A. `R.L. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR