BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE INTRA-ORAL BLADE

    MDR report key: 1417145 · Received April 3, 2009

    Report

    Report Number
    9616696-2009-00036
    Event Type
    Malfunction
    Date Received
    April 3, 2009
    Date of Event
    March 4, 2009
    Report Date
    March 5, 2009
    Manufacturer
    STRYKER IRELAND LTD
    Product Code
    DZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TWO BLADES SUBJECT TO THIS MDR HAVE TWO DIFFERENT LOT NUMBERS - 07088017 AS LISTED IN THIS REPORT AND ALSO 07092017. THE DEVICE MANUFACTURE DATE OF THE DEVICE WITH LOT NUMBER 07092017 IS 1ST APRIL 2007 AND THE EXPIRATION DATE IS 1ST APRIL 2012. ONCE THE RETURNED DEVICE HAS BEEN EVALUATED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING JAW SURGERY THAT TWO BLADES BROKE. IT WAS FURTHER REPORTED THAT NO BROKEN PIECES WERE LEFT BEHIND IN THE PATIENT. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE INTRA-ORAL BLADE SAW BLADES & ACCESSORIES DZH STRYKER IRELAND LTD 07088017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK