BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTION BUR GUARD

    MDR report key: 2851169 · Received October 29, 2012

    Report

    Report Number
    1811755-2012-03957
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 2, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    K961970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE EVENT WITHOUT AN EVALUATION OF THE DEVICE. ADDITIONAL INFORMATION WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED. THE DEVICE MANUFACTURE DATE CANNOT BE DETERMINED; THE LOT NUMBER OF THE PRODUCT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPACTION BUR GUARD BROKE DURING A PROCEDURE. NO ADVERSE CONSEQUENCES WAS ASSOCIATED WITH THE DEVICE, NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACTION BUR GUARD HWE STRYKER INSTRUMENTS KALAMAZOO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK