BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOD REV PROXIMAL BODY IMPACTOR

    MDR report key: 1850023 · Received September 27, 2010

    Report

    Report Number
    2249697-2010-01283
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED, "AS THE SURGEON WAS IMPACTING THE PROXIMAL BODY ONTO THE DISTAL STEM THE PIECE SNAPPED OFF INTO THE WOUND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOD REV PROXIMAL BODY IMPACTOR INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA TACH701

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other