BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERAL HEAD IMPACTOR

    MDR report key: 2020060 · Received March 10, 2011

    Report

    Report Number
    2249697-2011-00302
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 THAT, "WHEN THE SURGEON WAS HITTING A HUMERAL HEAD BY USING THE HUMERAL HEAD IMPACTOR, THE PLASTIC BROKE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMERAL HEAD IMPACTOR INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA P1TBR

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other