BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCIENT'X TRIBECA CAGE

    MDR report key: 1468248 · Received July 23, 2009

    Report

    Report Number
    3003807094-2009-00003
    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 SMALL BROKEN-OFF PORTION OF THE IMPLANT WAS RETURNED AND THE REMAINING PORTION OF THE DEVICE WAS IMPLANTED. THE SMALL PIECES RECEIVED ARE TOO SMALL AS TO CONDUCT A CONCLUSIVE INVESTIGATION. NO PATIENT COMPLICATIONS OR PROLONG TIME OF THE PROCEDURE WERE REPORTED. SURGEON FELT THAT THE REMAINING PORTION OF THE IMPLANT WILL NOT POSE ANY THREAT TO THE SAFETY OF THE PATIENT AND MADE A DECISION TO LEAVE THE DEVICE IMPLANTED. DEVICE HISTORY RECORDS WERE REVIEWED AND NO EVIDENCE WAS FOUND TO INDICATE NONCONFORMANCE TO THE MANUFACTURING AND/OR DESIGN SPECIFICATIONS. THE MOST LIKELY CAUSE OF THE EVENT IS EXCESSIVE FORCE APPLIED ON THE CAGE DURING INSERTION. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THE COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SMALL PORTION OF THE IMPLANT BROKE OFF DURING IMPACTION AT THE THREAD/INSERTER POINT. THE REMAINING PORTION OF THE DEVICE WAS IMPLANTED. 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 US620Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention