BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOSTAT STERNAL SAW

    MDR report key: 92811 · Received May 20, 1997

    Report

    Report Number
    2219689-1997-00266
    Event Type
    Malfunction
    Date Received
    May 20, 1997
    Date of Event
    April 15, 1997
    Report Date
    May 19, 1997
    Manufacturer
    SURGIQUIP, INC.
    Product Code
    DWH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    UPON TIGHTENING THE BLADE FIXATION CAP, THE BOTTOM DISC BEGAN TO SPIN. THIS EVENT OCCURRED PRIOR TO THE SURGICAL PROCEDURE; THEREFORE, THERE WAS NO ADVERSE EFFECT TO ANY PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOSTAT STERNAL SAW INSTRUMENT DWH SURGIQUIP, INC. NA 07940S01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other