BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEG THREADED 4.0X35.0MM

    MDR report key: 1242615 · Received November 20, 2008

    Report

    Report Number
    1818910-2008-05679
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    November 18, 2008
    Report Date
    November 18, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXT
    PMA / PMN Number
    K060290
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED, AS THE LOT NUMBERS REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WERE NOT PROVIDED. PROVIDED INFORMATION MARKED ON THE DEVICE EXPERIENCE REPORT IS MARKED THAT THE PRODUCTS ARE NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR CONTRIBUTING TO THE REPORTED EVENT. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY WARSAW CONSIDERS THE INVESTIGATION CLOSED. SHOULD THE PRODUCTS AND/OR ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEG THREADED 4.0X35.0MM 87LXT LXT DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention