BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QWIX FIXATION SCREW - 3MM DIAM. X18MM LG-STER

    MDR report key: 2497917 · Received March 12, 2012

    Report

    Report Number
    9615741-2012-00012
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    February 9, 2012
    Report Date
    March 12, 2012
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HWC
    PMA / PMN Number
    K050346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA RECEIVED A COPY OF THE UF/IMPORTER REPORT #310001-2012-0003 FROM THE USER FACILITY WHICH THEY FILED WITH FDA. THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT A PT WAS UNDERGOING A RIGHT FOOT BUNIONECTOMY WHEN THE INTEGRA SCREW IMPLANT HEAD CRACKED. THE SCREW WAS RETAINED IN THE PT. AN ADD'L SCREW WAS PLACED AT A DIAGONAL TO THE CRACKED SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QWIX FIXATION SCREW - 3MM DIAM. X18MM LG-STER QWIX HWC NEWDEAL S.A. EKRE

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR