BEUDAMED
    FDA Adverse Event Summary report: N

    4-VANE

    MDR report key: 1385950 · Received May 15, 2009

    Report

    Report Number
    MW5011088
    Date Received
    May 15, 2009
    Date of Event
    April 2, 2009
    Report Date
    May 15, 2009
    Manufacturer
    SOLCO BIOMEDICAL CO., LTD
    Product Code
    MCV
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SPINE SCREW BROKE INSIDE PT. WE WERE TOLD TO FILE A MEDICAL DEVICE REPORT. RESURGERY DONE TO REMOVE BROKEN SCREW AND FIX. ORIGINAL SURGERY DATE 2008. IMPLANT USED 10-VANE NUT, TWO CROSS-LINKS. PT SUFFERED FROM POST-OP- ERATIVE INFECTION RESULTING IN REOPERATION TO CLEAN INFECTED AREA APPROXIMATELY 2 WEEKS AFTER SURGERY (PRIMARY). SECOND REOPERATION IN 2009 TO REMOVE AND REPLACE LOOSE SCREWS. BROKEN SCREWS WERE RETURNED FOR INSPECTION THAT WERE TAKEN OUT THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4-VANE VANE PEDICLE SCREW MCV SOLCO BIOMEDICAL CO., LTD 7470807

    Patients

    Seq Age Sex Outcome Treatment
    1