BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLIDLOK HEK TIP 3.5MM

    MDR report key: 956274 · Received November 28, 2007

    Report

    Report Number
    1818910-2007-04170
    Event Type
    Malfunction
    Date Received
    November 28, 2007
    Date of Event
    July 26, 2007
    Report Date
    October 31, 2007
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    A SOLIDLOK HEX TIP FAILED DURING END CAP INSERTION. THE BROKEN PIECE WAS LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLIDLOK HEK TIP 3.5MM 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR Required Intervention