BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 5092107 · Received September 21, 2015

    Report

    Report Number
    0001811755-2015-03473
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    August 28, 2015
    Report Date
    August 28, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THAT THE HANDPIECE WOULD NOT REGISTER AND IT QUIT WORKING DURING THE PROCEDURE. THERE WAS A 30 MINUTE DELAY TO OBTAIN A BACKUP DEVICE. NO ADDITIONAL ANESTHESIA WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622026 CORE IMPACTION DRILL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1