BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE PTC SPINAL SYSTEM

    MDR report key: 5199916 · Received November 3, 2015

    Report

    Report Number
    1030489-2015-02896
    Event Type
    Malfunction
    Date Received
    November 3, 2015
    Date of Event
    October 12, 2015
    Report Date
    December 16, 2015
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE CAUSE OF EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS :VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED A ~3MM PORTION OF THE TOP FACE OF THE IMPLANT, WHICH INTERFACES DIRECTLY WITH THE INSERTER. OPTICAL AND MICROSCOPIC EXAMINATION OF THE RETURNED PORTION OF THE IMPLANT IDENTIFIED A BRITTLE FRACTURE WITH RAYS EMANATING FROM THE ROOT OF THE THREAD TOOTH, AND WITNESS MARKS ON THE TOP FACE OF THE IMPLANT, CONSISTENT WITH SIGNIFICANT FORCE DURING ATTEMPTED IMPLANTATION. THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG #3993210 AND 510K# (B)(4) IS APPROVED FOR SALE IN US.

    Description of Event or Problem · 1

    TYPE OF PROCEDURE: TRANSFORAMINAL LUMBAR INTERBODY FUSION IT WAS REPORTED THAT ON (B)(6) 2015, INTRA-OP, AS THE SURGEON PUT CAGE IN THE PLACE FROM THE INTERVERTEBRAL ROOM, A LITTLE BIT OF 10MM X 5MM OF THE CAGE BROKE, FROM THE INSERTER ATTACHMENT SIDE. THE SURGEON REMOVED THE BROKEN PIECES 10X5MM. THE REST OF THE CAGE DID NOT FALL TO PIECES AND WAS STABLE IN THE INTERVERTEBRAL ROOM. THE REST OF THE CAGE WAS NOT REMOVED AS IT WAS STRONG IN THE INTERVERTEBRAL ROOM. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PATIENT WAS NOT INJURED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730037 CAPSTONE PTC SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MDT SOFAMOR DANEK PUERTO RICO MFG NA H5197165

    Patients

    Seq Age Sex Outcome Treatment
    1