BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE SUMEX DRILL

    MDR report key: 8785030 · Received July 12, 2019

    Report

    Report Number
    0001811755-2019-02266
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 14, 2019
    Report Date
    March 4, 2020
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    UDI-DI
    04546540534125
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP REPORT SUBMITTED TO DOCUMENT DEVICE EVALUATION RESULTS.

    Description of Event or Problem · 0

    THE SALES REP REPORTED THAT THE DEVICE OVERHEATED DURING A PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT THE DEVICE OVERHEATED DURING TESTING.  THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579591 CORE SUMEX DRILL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO 5400130000 04546540534125

    Patients

    Seq Age Sex Outcome Treatment
    1