BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FACET FIXATION SYSTEM

    MDR report key: 1579037 · Received December 22, 2009

    Report

    Report Number
    3004744230-2009-00001
    Event Type
    Malfunction
    Date Received
    December 22, 2009
    Date of Event
    December 9, 2009
    Report Date
    December 21, 2009
    Manufacturer
    US SPINE INC.
    Product Code
    MRW
    PMA / PMN Number
    K061041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MODEL #60-5001-009. ADDITIONAL CATALOG #60-5001-009. ADDITIONAL LOT #102674. THE IMPLANTS WERE SURGICALLY REMOVED AND RETURNED TO US SPINE. UPON INITIAL INVESTIGATION, IT WAS NOTED THAT THE SCREW THREADED EASILY THROUGH THE DISTAL LOCKING WASHER. TYPICALLY, THE SCREW SHOULD ONLY BE ABLE TO BE TURNED ABOUT 2 THREADS THROUGH THE WASHER AND THEN A SCREWDRIVER SHOULD BE USED TO ADVANCE THE SCREW THROUGH THE WASHER. THIS INDICATES THAT THE WASHER LOCKING MECHANISM EITHER WAS DAMAGED OR DID TO ACTIVATE. THE LOCKING MECHANISM WORKS BY CAUSING INTERFERENCE BETWEEN THE SCREW AND WASHER THREADS. A 0.016" SLOT IS MACHINED AT THE DISTAL TIP OF THE WASHER. THIS TIP IS THEN BENT (OPENED) TO 12 DEGREES (+3/-0 DEGREES). THE BENDING THIS TAB CAUSES THE SCREW/THREAD INTERFERENCE.

    Description of Event or Problem · 1

    DURING ROUTINE 6 WEEK FOLLOW UP X-RAY SHOWED THAT FACET BOLT CONSTRUCT HAD DIS-ASSEMBLED. PATIENT DID NOT HAVE ANY SYMPTOMS RELATED TO THE CONSTRUCT DIS-ASSEMBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FACET FIXATION SYSTEM FACET BOLT MRW US SPINE INC. 60-5001-030 102668

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention