BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCIENT'X TRIBECA CAGE

    MDR report key: 1468246 · Received July 23, 2009

    Report

    Report Number
    3003807094-2009-00002
    Event Type
    Malfunction
    Date Received
    July 23, 2009
    Date of Event
    June 17, 2009
    Report Date
    July 22, 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 OF THE DEVICE WAS CONFIRMED. DEVICE HISTORY RECORDS WERE REVIEWED AND NO EVIDENCE WAS FOUND TO INDICATE NONCONFORMANCE 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 INSERTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAGE BROKE DURING IMPACTION. THE BROKEN PIECES WERE RETRIEVED. THE BROKEN DEVICE WAS NOT IMPLANTED. ANOTHER DEVICE WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    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 US611Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention