BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAG SCREW

    MDR report key: 2821910 · Received November 7, 2012

    Report

    Report Number
    2520274-2012-02951
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 1, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    MJO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED DATE OF EVENT IS (B)(6) 2012. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TWO LAG SCREWS IN THE FOOT ON (B)(6) 2011. IT WAS REPORTED THAT ONE OF THE LAG SCREW BROKE POST-OPERATIVE ON AN UNKNOWN DATE IN (B)(6) 2012. THE PATIENT WILL BE GETTING A SECOND OPINION BEFORE HE CONSIDERS HAVING THE SCREW EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAG SCREW MJO SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR LAG SCREW