BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL

    MDR report key: 978178 · Received January 9, 2008

    Report

    Report Number
    3005663955-2007-00006
    Event Type
    Injury
    Date Received
    January 9, 2008
    Date of Event
    December 6, 2007
    Report Date
    December 27, 2007
    Manufacturer
    PRECISION EDGE SURGICAL PRODUCTS
    Product Code
    HTW
    PMA / PMN Number
    K051309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEWED DRILL BIT, MFR DATA, AND RECEIVED PHYSICIAN OPINION. FIRST DOCUMENTED FAILURE OF DRILL BIT.

    Description of Event or Problem · 1

    DRILL BIT BROKE OFF INSIDE PATIENT BONE DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL CANNULATED DRILL HTW PRECISION EDGE SURGICAL PRODUCTS 500022 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR