BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED LONG SABER ATTACHMENT

    MDR report key: 2233170 · Received July 22, 2011

    Report

    Report Number
    1811755-2011-02632
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AS OF THE DATE OF THIS REPORT. THIS REPORT WILL BE UPDATED WHEN THE EVAL IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATTACHMENT OVERHEATED DURING TESTING. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGLED LONG SABER ATTACHMENT HBE STRYKER INSTRUMENTS KALAMAZOO 11098

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK