BEUDAMED
    FDA Adverse Event Summary report: N

    2.5 CORTICAL SCREW

    MDR report key: 2101757 · Received May 13, 2011

    Report

    Report Number
    2101757
    Date Received
    May 13, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 13, 2011
    Manufacturer
    SYNTHES
    Product Code
    HWC
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    A 2.5 SYNTHES CORTICAL SCREW BROKE WHILE BEING TAKEN OUT FROM THE PT'S RIGHT ANKLE; THE BROKEN PART WAS RETRIEVED FROM THE PT. FLAT PLATE X-RAY WAS ORDERED BY SURGEON AND X-RAY FILM WAS VISUALIZED AND CLEARED ALSO BY THE SURGEON. SCREW SENT TO PATHOLOGY WITH REST OF HARDWARE REMOVED FROM PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.5 CORTICAL SCREW SCREW, FIXATION, BONE HWC SYNTHES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR