BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELLA-P

    MDR report key: 1153244 · Received September 5, 2008

    Report

    Report Number
    3004719693-2008-00001
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 4, 2008
    Report Date
    September 5, 2008
    Manufacturer
    INNOVASIS, INC.
    Product Code
    MNI
    PMA / PMN Number
    K042143
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF RETURNED UNIT INCLUDED TESTING THE INTERNAL THREADS OF THE DRIVER BODY WITH GO AND NO-GO PLUG GAGES. THE NO-GO GAGE COULD, WITH MODERATE EFFORT, BE INSERTED INTO THE DRIVER BODY. THE DHR FOR THIS LOT WAS ICN 00693, WHICH INCLUDED AN NCMR (NON-CONFORMING MATERIAL REPORT) FOR THIS CHARACTERISTIC . THAT LOT WAS SUBJECTED TO 100% INSPECTION AND ONLY UNITS THAT WOULD NOT ACCEPT THE GAGE WERE RELEASED FOR DISTRIBUTION. THE SCREW AND LOCKING CAP WERE ASSEMBLED TO A 6MM ROD AND FOUND TO FUNCTION WELL AT THE PRESCRIBED TORQUE OF 80 INCH-POUNDS. IT APPEARS THAT THE SCREW WAS SLIGHTLY SPRUNG DURING INSERTION OR THE PERIOD OF IMPLANTATION BUT WOULD STILL ACCEPT THE SPECIFIED TORQUE. THE EVALUATION WAS INCONCLUSIVE AS TO WHY THE LOCKING CAP LOOSENED.

    Description of Event or Problem · 1

    FIVE MONTHS AFTER IMPLANT FOR SPINAL FUSION, PATIENT COMPLAINED OF PAIN. X-RAY REVEALED LOCKING CAP OF PEDICLE SCREW HAS COME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELLA-P PEDICLE SCREW SYSTEM MNI INNOVASIS, INC. 6.5 X 40MM 0701

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R LOCKING CAPS| 6MM X 120MM RODS