BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALTY HEAD CENTER ACCOLADE BROACH HANDLE PER F

    MDR report key: 1864589 · Received October 5, 2010

    Report

    Report Number
    2249697-2010-01323
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 10, 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
    AS
    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

    DURING PREPARATION FOR USE, THE NURSE UNIT MANAGER DISCOVERED THE DEVICE IS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECIALTY HEAD CENTER ACCOLADE BROACH HANDLE PER F INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA 674MKD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention