BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNTHES 1.3 X 4 MM SCREWS

    MDR report key: 792757 · Received December 7, 2006

    Report

    Report Number
    MW1041299
    Event Type
    Other
    Date Received
    December 7, 2006
    Date of Event
    November 22, 2006
    Report Date
    December 7, 2006
    Manufacturer
    SYNTHES INC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT RIGHT TEMPORAL CRANIOTOMY AND DEBULKING OF UNDERLYING GLIOMA. A FREE TEMPORAL BONE FLAP WAS FASHIONED. AT THE CONCLUSION OF THE SURGERY, THE BONE FLAP WAS SECURED WITH BIOPLATES AND SCREWS. THREE SCREWS SNAPPED DURING PLACEMENT. EACH WAS REMOVED. PHYSICIAN CALLED FOR A DIFFERENT SET OF SCREWS. BONE FLAP WAS SECURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES 1.3 X 4 MM SCREWS NEUROFIXATION SCREWS HWC SYNTHES INC 400.834 *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other