BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUCENT

    MDR report key: 2685290 · Received July 23, 2012

    Report

    Report Number
    3004893332-2012-00001
    Event Type
    Other
    Date Received
    July 23, 2012
    Date of Event
    July 5, 2012
    Report Date
    July 19, 2012
    Manufacturer
    SPINAL ELEMENTS, INC.
    Product Code
    MQP
    PMA / PMN Number
    K071724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVAL. (B)(4).

    Description of Event or Problem · 1

    THIS IS THE DESCRIPTION PROVIDED BY THE REP IN THE SURGERY. "DURING A SPINE FUSION SURGERY A SURGEON WAS MALLETING A CAGE INTO THE DISC SPACE WHEN THE CAGE BROKE. THE CAGE PUNCTURED THE DURA. WHEN THE SURGEON WAS MALLETING THE CAGE INTO PLACE (SEEMED LIKE HE WAS HITTING IT FOR LONGER THAN NORMAL AND IT WAS A 10X32 CAGE) THE CAGE CRACKED IN HALF. I DON'T KNOW IF THERE WAS AN ANGLE WHEN HE PUT IT IN. IT WAS HARD TO SEE. THEY PLUCKED SOME PIECES OUT BUT THE ANTERIOR PORTION OF THE CAGE WAS IN HALFWAY SO THEY DECIDED TO TAMP THAT PIECE IN DEEP AND PUT A 10X22 BEHIND IT (WHICH WENT IN WITHOUT INCIDENCE). AFTER FINISHING, THEY STITCHED THE DURA AND APPLIED DURASEAL AND DURAGEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUCENT INTERVETEBRAL BODY FUSION DEVICE MQP SPINAL ELEMENTS, INC. 10022-010 11032-511 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA