BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER

    MDR report key: 2171890 · Received June 11, 2006

    Report

    Report Number
    2171890
    Event Type
    Injury
    Date Received
    June 11, 2006
    Date of Event
    May 15, 2006
    Report Date
    May 23, 2006
    Manufacturer
    STRYKER
    Product Code
    HWE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING BILATERAL SAGITTAL SPLIT RAMUS OSTEOTOMIES WITH SCREW FIXATION AND THREE-PIECE SEGMENTAL LEFORT I MAXILLARY OSTEOTOMY FIXATION FOR MAXILLARY AND MANDIBULAR HYPOPLASIA. THE STRYKER TPS DRILL WAS NOTED TO BE EXTREMELY HOT DURING THE INITIAL PHASE OF THE RIGHT SIDED OSTEOTOMY AND IT WAS ALSO NOTED THAT THE HEAT GENERATED FROM THE SURGICAL HAND PIECE HAD BURNED THE INSIDE OF THE PT'S LOWER LIP ON THE RIGHT SIDE. IT APPEARED TO BE SUPERFICIAL AND WAS TREATED WITH SOME TOPICAL ANTIBIOTIC OINTMENT AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER CORE MICRO DRILL HWE STRYKER 0197

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR STRYKER TPS IRRIGATION SYSTEM: (B)(4)