BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYNCH TLIF 5 DEGREES X 11MM X 25MM CAGE

    MDR report key: 3102436 · Received May 1, 2013

    Report

    Report Number
    3006404071-2013-00005
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    November 22, 2011
    Report Date
    May 1, 2013
    Manufacturer
    SPINESMITH HOLDINGS, LLC
    Product Code
    MAX
    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 BROKE UPON EXTRACTION TO REPOSITION. THERE ARE NO DETAILS AVAILABLE CONCERNING PT ANATOMY BUT BASED ON THE SYSTEM DESIGN RISK MANAGEMENT FILE, THIS TYPE OF FRACTURE IS TYPICALLY A RESULT OF OPERATIONAL CONTEXT BASED ON PT ANATOMY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER INSERTION OF CYNCH TLIF 5 DEGREES X 11MM X 8MM IMPLANT, THE SURGEON WANTED TO CHANGE THE POSITIONING OF THE CAGE. WHILE TRYING TO BACK UP THE CAGE, A PIECE BROKE OFF AND WAS REMOVED. THE SURGEON REMOVED THE REST OF THE ENTIRE CAGE W/O DETRIMENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189972 CYNCH TLIF 5 DEGREES X 11MM X 25MM CAGE CYNCH TLIF SYSTEM MAX SPINESMITH HOLDINGS, LLC 0602-0080 47AM

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention