BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYNCH TLIF 5 DEGREES X 11MM X 25MM CAGE

    MDR report key: 3102435 · Received May 1, 2013

    Report

    Report Number
    3006404071-2013-00004
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    September 23, 2010
    Report Date
    May 1, 2013
    Manufacturer
    SPINESMITH HOLDINGS, LLC
    Product Code
    KWQ
    PMA / PMN Number
    K101085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DIMENSIONAL DISCREPANCIES WERE IDENTIFIED. MATERIAL AND PROCESSING REQUIREMENTS WERE TO SPECIFICATION. REVIEW OF PRODUCT LABELING AND THE SYSTEM SURGICAL TECHNIQUE DID NOT REVEAL AND DISCREPANCIES OR DEFICIENCIES. VISUAL EVAL DID NOT INDICATE ANY MATERIALS ABNORMALITIES AND CONFIRMS THAT IT WAS BROKEN AT THE INSERTER INTERFACE. THE IMPLANT IS LABELED FOR SINGLE USE ONLY AND MOST LIKELY BROKE AS A RESULT OF MULTIPLE INSERTIONS AND EXTRACTIONS DURING THE SURGICAL PROCEDURE WHILE ATTEMPTING TO REPOSITION WITHIN THE PT ANATOMY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT INSERTION, THE SURGEON INSERTED AND REMOVED THE CYNCH TLIF 5 DEGREES X 11MM X 25MM CAGE 2-3 TIMES, AND ON THE SURGEON'S THIRD ATTEMPT AT INSERTING THE IMPLANT, IT BROKE INTO TWO PIECES. THE SMALLER PIECE REMAINED ATTACHED TO THE IMPLANT HOLDER. THE LARGER PIECE WAS REMOVED FROM THE PT. THERE WAS A 10 MIN DELAY TO THE SURGERY, WITH NO DETRIMENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190688 CYNCH TLIF 5 DEGREES X 11MM X 25MM CAGE CYNCH TLIF SYSTEM KWQ SPINESMITH HOLDINGS, LLC 0602-0080 71AG

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention