BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR PLUSDRIVE Ø2 SELF-DRILL L4 TAN

    MDR report key: 2971283 · Received February 21, 2013

    Report

    Report Number
    1719045-2013-00391
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 23, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    PMA / PMN Number
    K102656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MEASURABLE DIMENSIONS COULD NOT BE CHECKED COMPLETELY BECAUSE THE PART OF THREADED TIP IS PARTLY MISSING. THE HEAD AND THE REMAINDER OF THE THREAD WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AN AO ASIF SPECIFICATION. THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS WAS NOT POSSIBLE SINCE WE ARE NOT AWARE OF THE CONCERNED LOT NUMBERS. THE INVESTIGATION OF THE COMPLAINED SCREW SHOWS THAT THE TIP IS FLATTENED DUE TO MECHANICAL OVERLOAD SITUATION WHILE INSERTION. WE ARE NOT ABLE TO DETERMINE AN EXACT CAUSE OF THIS OCCURRENCE AS NO CLINICAL DETAILS WERE PROVIDED. WE ASSUME THAT THE TIP OF THIS SCREW IS FLATTENED AS RESULT OF STRONG MECHANICAL CONTACT WITH VERY HARD UNKNOWN MEDIA OR HARD BONE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE PRODUCT WAS RETURNED AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE SURGEON CAN´T SCREW IT IN THE BONE. HE SAID IT WAS TOO BLUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77050 CORTSCR PLUSDRIVE Ø2 SELF-DRILL L4 TAN CORTSCREW PLUSDRIVE JEY SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1