BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 1030311 · Received April 15, 2008

    Report

    Report Number
    1811755-2008-00021
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 14, 2008
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION, SIGNIFICANT CORROSION WAS LOCATED INSIDE THE HANDPIECE. THE BEARINGS AND DRIVESHAFT BOTH HAD TO BE REPLACED AS A RESULT OF THE CORROSION. FURTHER INVESTIGATION DETERMINED THAT THE BUR GUARD HAD A SEIZED BEARING WITH ADD'L SIGNS OF CORROSION. BASED OFF OF THE INVESTIGATION FINDINGS, IMPROPER STERILIZATION PROCEDURES AT THE CUSTOMER ACCOUNT WAS LIKELY TO BE THE CONTRIBUTING FACTOR FOR THE HANDPIECE AND THE BUR GUARD TO FUNCTION IMPROPERLY.

    Description of Event or Problem · 1

    PER THE SALES REP, DURING A WISDOM TOOTH REMOVAL, THE PT RECEIVED A MINOR BURN TO THE LOWER RIGHT PORTION OF THE LIP. NO MEDICAL INTERVENTION WAS REQUIRED TO TREAT THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE IMPACTION DRILL CORE SYSTEM DZJ STRYKER INSTRUMENTS KALAMAZOO 0604009793

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK