BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE INTRA-ORAL BLADE

    MDR report key: 1346534 · Received March 14, 2009

    Report

    Report Number
    1346534
    Event Type
    Malfunction
    Date Received
    March 14, 2009
    Date of Event
    February 10, 2009
    Report Date
    March 14, 2009
    Manufacturer
    STRYKER
    Product Code
    DZH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BLADE TIP OF STRYKER CORE INTRA-ORAL BLADE #5400-31-32 BROKE OFF DURING USE. BOTH PIECES REMOVED FROM FIELD. NO APPARENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE INTRA-ORAL BLADE CORE INTRA-ORAL BLADE DZH STRYKER NA 31309010825501780*08255017

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR