BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABILIZATION SCREW, 4.3MM DIA X 38MM LGTH

    MDR report key: 1081570 · Received July 25, 2008

    Report

    Report Number
    9615741-2008-00010
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    May 20, 2008
    Report Date
    July 25, 2008
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT WILL NOT BE REC'D FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SCREW BENT AS IT WAS BEING INSERTED. IN A TELEPHONE CALL, THE SURGEON REPORTED THAT THE DEVICE WAS LEFT IN PLACE AND THE MALFUNCTION IS NOT LIKELY TO ADVERSELY AFFECT THE OUTCOME OF THE PROCEDURE FOR CORRECTION OF BUNION DEFORMITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABILIZATION SCREW, 4.3MM DIA X 38MM LGTH LOWER EXTREMITY FIXATION SCREW HWC NEWDEAL S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR