BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADJUSTABLE DRILL BIT & ADJUSTABLE STOP

    MDR report key: 61514 · Received January 9, 1997

    Report

    Report Number
    1030489-1997-00001
    Event Type
    Injury
    Date Received
    January 9, 1997
    Date of Event
    December 9, 1996
    Report Date
    January 9, 1997
    Manufacturer
    SOFAMOR DANEK
    Product Code
    HXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR DATE FOR THE 981-614 WAS 8/12/94. BOTH ITEMS WERE FOUND TO MEET PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    INTRAOPERATIVELY, SURGEON EXPERIENCED DIFFICULTY USING THE DRILL BIT AND DRILL STOP. POSTOPERATIVELY, THE PT SHOWED A PARTIAL DEFICIT OF LEFT C5, BUT HAS NOW REGAINED NEUROLOGIC FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADJUSTABLE DRILL BIT & ADJUSTABLE STOP DRILL BIT & STOP HXY SOFAMOR DANEK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other