BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCIENT'X TRIBEC CAGE

    MDR report key: 2651354 · Received August 27, 2009

    Report

    Report Number
    3003807094-2009-00004
    Event Type
    Malfunction
    Date Received
    August 27, 2009
    Date of Event
    July 27, 2009
    Report Date
    August 27, 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 IMPLANT WAS RETURNED TO THE MANUFACTURER WHERE THE BREAKAGE WAS CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO EVIDENCE WAS FOUND TO INDICATE NON-CONFORMANCE TO THE MANUFACTURING AND/OR DESIGN SPECIFICATIONS. NO CONCLUSION CAN BE MADE AT THIS TIME. THE MOST LIKELY CAUSE OF THE EVENT IS EXCESSIVE FORCE PLACED ON THE CAGE DURING IMPACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAGE BROKE DURING IMPACTION. THE BROKEN DEVICE WAS NOT IMPLANTED. THE BROKEN DEVICE AND PIECES WERE RETRIEVED. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCIENT'X TRIBEC CAGE INTERVERTEBRAL BODY FUSION DEVICE MAX SCIENT'X USA, INC. NA US L89Q

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention