BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE INTRA-ORAL BLADE

    MDR report key: 1757122 · Received June 17, 2010

    Report

    Report Number
    9616696-2010-00250
    Event Type
    Malfunction
    Date Received
    June 17, 2010
    Date of Event
    May 25, 2010
    Report Date
    May 25, 2010
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    DZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLADE SUBJECT TO THIS MDR WAS RETURNED FOR EVAL. IT WAS VISUALLY CONFIRMED THAT THE BLADE BROKE AT THE JOINT TO THE ARBOR. MEASUREMENTS CARRIED OUT ON THE BLADE CONFIRMED THAT ALL FEATURES CONFORMED TO REQUIRED SPECIFICATION. A DOCUMENTATION REVIEW CONFIRMED THAT NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE ROOT CAUSE FOR THE BREAKAGE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADE BROKE AT THE ARBOR DURING AN ORAL SURGICAL PROCEDURE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE INTRA-ORAL BLADE SAW BLADES AND ACCESSORIES DZH STRYKER IRELAND LTD. 10060017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK