BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE INTRA-ORAL BLADE

    MDR report key: 1950141 · Received December 8, 2010

    Report

    Report Number
    9616696-2010-00366
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    DZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    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 WELD BETWEEN THE BLADE AND THE SHANK. THE RETURNED BLADE MEASURED WHERE POSSIBLE AND ALL CRITICAL SPECS WERE MET. MFG RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORAL SURGERY IN THE MANDIBULAR RAMUS REGION, THE BLADE BROKE AT THE WELD BETWEEN THE BLADE AND THE SHANK. IT WAS FURTHER REPORTED THAT AS A RESULT OF THIS BREAKAGE, A RECIPROCATING BLADE WAS USED TO COMPLETE THE PROCEDURE. THE SURGICAL TECHNIQUE WAS CHANGED FROM A PERPENDICULAR OSTEOTOMY TO HORIZONTAL OSTEOTOMY AS A RESULT. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE INTRA-ORAL BLADE SAW BLADES & ACCESSORIES DZH STRYKER IRELAND LTD. 10169027

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK