BEUDAMED
    FDA Adverse Event Other Summary report: N

    WWIX SCREW 7.5MM DIA X 80MM LENGTH STERILE

    MDR report key: 2519732 · Received April 4, 2012

    Report

    Report Number
    9615741-2012-00019
    Event Type
    Other
    Date Received
    April 4, 2012
    Date of Event
    March 23, 2012
    Report Date
    April 4, 2012
    Manufacturer
    NEWDEAL SAS
    Product Code
    HWC
    PMA / PMN Number
    K050346
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE PATIENT HAD PREVIOUS SURGERY TO PLACE THE TWO SCREWS IN THE CALCANEUS THROUGH THE TALUS FOR A SUBTALOR FUSION PROCEDURE. THE SURGEON THEN BROUGHT THE PATIENT BACK FOR A CALCANEAL OSTEOTOMY PROCEDURE. DURING THE PROCEDURE, THE SURGEON ATTEMPTED, WITHOUT SUCCESS, FOR ABOUT FOUR HOURS, TO REMOVE THE IMPLANTED SCREWS, USING VARIOUS INSTRUMENTS FROM THE EZ OUT SYSTEM. SHE THEN DECIDED TO CLOSE THE PATIENT AND DO FURTHER SURGERY AT A LATER TIME WHEN SHE KNEW EXACTLY HOW TO REMOVE THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WWIX SCREW 7.5MM DIA X 80MM LENGTH STERILE NA HWC NEWDEAL SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other