BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABLECUT BLADE 90X25X1.47

    MDR report key: 598368 · Received April 27, 2005

    Report

    Report Number
    2950261-2005-00001
    Event Type
    Malfunction
    Date Received
    April 27, 2005
    Date of Event
    February 21, 2005
    Report Date
    April 25, 2005
    Manufacturer
    SYNVASIVE TECHNOLOGY, INC.
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORT STATED A SAW BLADE WAS RETURNED WITH THE COMPLAINT "THE EDGE OF THE BLADE CHIPPED OFF DURING THE SURGERY". THE REPORT REQUESTED CO CHECK CO'S DHR REGARDING THIS PRODUCT. THE REPORT STATES SURGERY TIME WAS EXTENDED BY 1 HOUR WHILE PART WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABLECUT BLADE 90X25X1.47 ORTHOPAEDIC SURGICAL SAW BLADE HWE SYNVASIVE TECHNOLOGY, INC. 0011-2415 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *