BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER FOR FIXATION OF UNIVERSAL TRACKER TO MAYFIELD CLAMP

    MDR report key: 17582553 · Received August 21, 2023

    Report

    Report Number
    3015967359-2023-01870
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    July 26, 2023
    Report Date
    November 3, 2023
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    HAW
    UDI-DI
    04546540245052
    PMA / PMN Number
    K993239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE: D9, H3, H6 DEVICE EVALUATION: FOLLOW-UP REPORT SUBMITTED TO DOCUMENT THE DEVICE EVALUATION.

    Description of Event or Problem · 0

    PER THE CUSTOMER, THE PART WHERE YOU PUT THE TRACKER ON IS LOOSE, NOT TIGHTENING. THIS COULD LEAD TO INACCURACIES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    PER THE CUSTOMER, THE PART WHERE YOU PUT THE TRACKER ON IS LOOSE, NOT TIGHTENING. THIS COULD LEAD TO INACCURACIES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461606 ADAPTER FOR FIXATION OF UNIVERSAL TRACKER TO MAYFIELD CLAMP NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP A/05/2015 04546540245052

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown