BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVER BOLT SCREWS

    MDR report key: 1033268 · Received March 26, 2008

    Report

    Report Number
    1033268
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 26, 2008
    Manufacturer
    VERTIFLEX, INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    THREE VERTIFLEX (SILVER BOLT SCREWS) BENT AND BROKE AS BEING IMPLANTED. ALL PIECES RETRIEVED. ANOTHER DEVICE WAS USED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVER BOLT SCREWS SCREW, ORTHOPEDIC HWC VERTIFLEX, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR