BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCIENT'X TRIBECA CAGE

    MDR report key: 2651363 · Received November 10, 2009

    Report

    Report Number
    3003807094-2009-00005
    Event Type
    Malfunction
    Date Received
    November 10, 2009
    Date of Event
    October 6, 2009
    Report Date
    November 9, 2009
    Manufacturer
    SCIENT'X USA, INC.
    Product Code
    MAX
    PMA / PMN Number
    K080588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON REPORTED THAT HE DOES NOT CONSIDER THIS TO BE A DEVICE RELATED PROBLEM. HE BELIEVES THAT THE USE OF THE PROPER HEIGHT CAGE WAS LIMITED BY HIS EXPOSURE OF THE SITE AND THAT THE DEVICE HE SELECTED AND IMPLANTED WAS IN FACT UNDERSIZED FOR THE DISC SPACE. THE IMPLANT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORDS FOR LOT US612Q WERE REVIEWED AND NO EVIDENCE WAS FOUND TO INDICATE NON-CONFORMANCE TO THE MANUFACTURING AND/OR DESIGN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED IN THE L5/S1 DISC SPACE. THE CAGE BACKED OUT. DOCTOR PERFORMED REVISION SURGERY, REMOVED THE CAGE AND PACKED THE DISC SPACE WITH BONE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCIENT'X TRIBECA CAGE INTERVERTEBRAL BODY FUSION DEVICE MAX SCIENT'X USA, INC. NA US612Q

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention