BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DVR ANATOMIC STANDARD LEFT

    MDR report key: 2111496 · Received May 13, 2011

    Report

    Report Number
    1818910-2011-08486
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    LXT
    PMA / PMN Number
    K050932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT 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

    PT WAS REVISED TO ADDRESS A DVRA-L PLATE WHICH BROKE INTO TWO PIECES ONE MONTH POST-OP. PLATE WAS BROKEN AT THE DISTAL SCREW HOLE IN THE SHAFT OF THE PLATE. THE SURGEON SUSPECTS THAT THE INCIDENT WAS CAUSED BY EITHER A TRAUMA DUE TO A VERY HIGHLY ACTIVE AND OCCASIONALLY NONCOMPLIANT PT, OR A MANUFACTURING ERROR IN THE PARTICULAR PLATE. ACTUAL CAUSE IS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention