BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CSS CANNULATED SCREW SYSTEM

    MDR report key: 1903489 · Received November 16, 2010

    Report

    Report Number
    3005039508-2010-00019
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    September 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    ORTHOHELIX SURGICAL DESIGN
    Product Code
    HWC
    PMA / PMN Number
    K060428
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL REPORTED THAT THE PT WAS NON-COMPLIANT AND MORBIDLY OBESE. OBESITY AND NON-COMPLIANCE ARE CONTRAINDICATIONS OF THIS PRODUCT.

    Description of Event or Problem · 1

    BROKEN SCREW WITH PART OF THE BROKEN SCREW REMOVED. FLAT FOOT RECONSTRUCTION DONE IN (B)(6) ON 2010. THE RECONSTRUCTION FAILED. THE PT BMI OF 41 AND WALKED ON THE LIMB EARLY IN THE POST-OPERATIVE PERIOD. SHE PRESENTED THE BROKEN HARDWARE AT THE LATERAL COLUMN WHICH CREATED THE COLLAPSE. PART OF THE HARDWARE WAS REMOVED WITH THE TIP OF THE SCREW LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSS CANNULATED SCREW SYSTEM BONE FIXATION SCREWS HWC ORTHOHELIX SURGICAL DESIGN MSD-011-40-XX N782

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention