BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE 100 TUBULAR 6 HOLE

    MDR report key: 2112773 · Received May 18, 2011

    Report

    Report Number
    1818910-2011-08913
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDL
    PMA / PMN Number
    K920738
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 FOR THE PLATE AND THE PART/LOT FOR THE SCREW WERE NOT PROVIDED. PROVIDED INFO STATES THE PT IS VERY THIN CAUSING PAIN IN THE DISTAL FIBULA. A TWO-YEAR SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR PAIN FOR THE PLATE PRODUCT NUMBER. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFO PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS 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 REVISED FOR PAIN IN DISTAL FIBULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATE 100 TUBULAR 6 HOLE 87 JDL JDL DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention