BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4/2.7MM VA-LCP FIRST TMT FUSION PLATE/STANDARD

    MDR report key: 2864035 · Received December 10, 2012

    Report

    Report Number
    1719045-2012-01298
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 12, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    PMA / PMN Number
    K100776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH VA-LCP FIRST TMT FUSION PLATE AND SCREW CONSTRUCT ON AN UNKNOWN DATE. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2012 FOR REMOVAL OF HARDWARE DUE TO A NON-UNION OF A TRIPLE ARTHRODESIS OF THE FOOT. PATIENT WAS REVISED WITH NEW SYNTHES HARDWARE. EXPLANTED HARDWARE WERE DISCARDED OF. THIS IS 1 OF 10 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.4/2.7MM VA-LCP FIRST TMT FUSION PLATE/STANDARD PLATE HRS SYNTHES MONUMENT 6806408

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention SCREWS