BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM TI CANC EXPANSIONHEAD SCREW SELF-TAPPING 16MM

    MDR report key: 2863971 · Received December 10, 2012

    Report

    Report Number
    8030965-2012-01512
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    PMA / PMN Number
    K031276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    DURING INSERTION OF TWO EXPANSION HEAD SCREWS INTO A CSLP GOLD PLATE FOR AN ACDF AT C6-C7, THE TWO SCREWS WOULD NOT FIT THROUGH THE PLATE. SURGEON REMOVED THE CSLP GOLD PLATE AND USED A CSLP VARIABLE ANGLE PLATE WHICH WAS IMPLANTED WITHOUT ISSUE. THE SAME TWO EXPANSION HEAD SCREWS THAT WOULD NOT FIT THROUGH THE CLP GOLD PLATE WERE IMPLANTED INTO THE CSLP VARIABLE ANGLE PLATE WITHOUT ISSUE. ALL SCREWS SEATED CORRECTLY AND THE SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM. THIS IS THE 3RD OF 3 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM TI CANC EXPANSIONHEAD SCREW SELF-TAPPING 16MM 4.5MM TI CANC EXPANSIONHEAD SCREW KWQ SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR PLATE, SCREWS