BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFT FILTER FOR RIA-STERILE

    MDR report key: 2033487 · Received March 23, 2011

    Report

    Report Number
    1719045-2011-00128
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFO HAS NOT BEEN PROVIDED, ADD'L INFO HAS BEEN REQUESTED. SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. INVESTIGATION IS ONGOING, NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON FIRST USE, THE GRAFT FILTER FOR RIA WAS MISSING THE PIECE INSIDE THAT FACILITATES COLLECTION. THE GRAFT WAS NOT COLLECTED AND WENT DIRECTLY INTO THE SUCTION CANISTER. SURGEON SELECTED ANOTHER FILTER FROM THE SAME LOT # AND REAMED UP A SIZE TO OBTAIN GRAFT. THE NON-UNION TIBIA EX NAIL WAS NOT DAMAGED IN THE PROCEDURE AND A LARGER NAIL WAS USED TO COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFT FILTER FOR RIA-STERILE GRAFT FILTER FOR RIA-STERILE HTO SYNTHES MONUMENT NA 6503204

    Patients

    Seq Age Sex Outcome Treatment
    1 NI RIA SYSTEM