BEUDAMED
    FDA Adverse Event Other Summary report: N

    Titanium Cortex Screw

    MDR report key: 535143 · Received July 12, 2004

    Report

    Report Number
    535143
    Event Type
    Other
    Date Received
    July 12, 2004
    Date of Event
    June 9, 2004
    Report Date
    July 12, 2004
    Manufacturer
    Synthes USA, Inc.
    Product Code
    HWC
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    The head of an 8 mm screw broke while screwing into bone.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 8/12/04: THE LOT NUMBER OF THE SUBJECT DEVICE WAS NOT PROVIDED. A COMPLAINT HAS BEEN OPENED ON THE SUBJECT DEVICE. A MEDWATCH REPORT HAS NOT BEEM CREATED AS NO ADDITIONAL SURGERY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Titanium Cortex Screw Screw HWC Synthes USA, Inc. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Not known