BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 4242346 · Received November 11, 2014

    Report

    Report Number
    0001811755-2014-04028
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    EIA
    PMA / PMN Number
    K032117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT SUBMITTED TO DOCUMENT DEVICE EVALUATION RESULTS. THE DEVICE EVALUATION COULD NOT BE COMPLETED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE WAS OVERHEATING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE WAS OVERHEATING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726770 MICRO SAGITTAL SAW UNIT, OPERATIVE DENTAL EIA STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1