BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMB DRILL MD SERIES MEDIUM STRAIGHT MICRODRILL ATTACHMENT

    MDR report key: 7933433 · Received October 4, 2018

    Report

    Report Number
    7933433
    Event Type
    Malfunction
    Date Received
    October 4, 2018
    Date of Event
    August 9, 2018
    Report Date
    September 27, 2018
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    EIA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ELDERLY PT. HERE FOR MULTIPLE TEETH EXTRACTIONS AND IMPLANTS. WHILE PT. WAS STILL IN SURGERY, HE WAS BURNED ON THE RIGHT SIDE OF HIS LOWER LIP BY A DRILL BEING USED. PER INITIAL REPORT, IT WAS A STRYKER REMI DRILL AND REPORTEDLY THE SURGEON PERFORMING THE PROCEDURE REPORTED THE HAND PIECE WAS HOT AND HE NOTICED THE LIP BURN. THE EQUIPMENT WAS REMOVED AND PLACED OUT OF SERVICE. MANUFACTURER RESPONSE FOR STRYKER REMI DRILL, STRYKER (PER SITE REPORTER). NO FORMAL RESPONSE; REVIEW PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777673 REMB DRILL MD SERIES MEDIUM STRAIGHT MICRODRILL ATTACHMENT UNIT, OPERATIVE DENTAL EIA STRYKER INSTRUMENTS 5100-015-250

    Patients

    Seq Age Sex Outcome Treatment
    1 24090 DA Other