BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCIENT'X TRIBECA CAGE

    MDR report key: 1483082 · Received July 20, 2009

    Report

    Report Number
    3003807094-2009-00001
    Event Type
    Malfunction
    Date Received
    July 20, 2009
    Date of Event
    March 18, 2009
    Report Date
    July 17, 2009
    Manufacturer
    SCIENT'X USA, INC.
    Product Code
    MAX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT WAS RETURNED TO THE MFR WHERE THE BREAKAGE OF THE DEVICE WAS CONFIRMED. DEVICE HISTORY RECORD WERE REVIEWED AND NO EVIDENCE WAS FOUND TO INDICATE NONCONFORMANCE TO THE MFG AND/OR DESIGN SPECS. THE MOST LIKELY CAUSE OF THE EVENT IS EXCESSIVE FORCE APPLIED 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.

    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. US606Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention