BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAZZ SYSTEMS

    MDR report key: 6633200 · Received June 12, 2017

    Report

    Report Number
    3007675554-2017-00002
    Event Type
    Injury
    Date Received
    June 12, 2017
    Date of Event
    March 19, 2017
    Report Date
    May 16, 2017
    Manufacturer
    IMPLANET
    Product Code
    OWI
    UDI-DI
    03607503507127
    PMA / PMN Number
    K160226
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EXPERTISE BY SURGEON: A (B)(6) PATIENT: INITIAL INTERVENTION: CORRECTION BY THORACO LUMBAR INSTRUMENTATION WITH PEDICLE SCREWING. LIMIT OF UPPER END IN MIDDLE THORACIC BY 2 JAZZ CLAW HOOKS, NO PROTECTION OF UPPER THORACIC SPINE. DISASSEMBLY OF THE 2 JAZZ CLAW TOOK PLACE WITH PROBABLE REMOVAL OF THE HOOKS PLACED IN FIRST INTENTION. THE ASSUMPTIONS MADE ARE AS FOLLOWS: PRIMARY CAUSE: FRACTURE OF THE LAST SCREWED VERTEBRA AND THE SUPRA VERTEBRA CAUSING A LOCAL KYPHOSIS, AND CONSEQUENTLY THE PULL OUT OF THE JAZZ CLAW. SECONDARY CAUSE: THE JAZZ CLAW POSITIONED IN THE MIDDLE THORACIC ARE NOT USED IN THEIR MAXIMUM CONFIGURATION (STRONG MECHANICAL CONSTRAINTS ON A KYPHOSED AND STIFF SPINE) SECONDARY CAUSE: STOPPING THE INSTRUMENTATION IN THE MIDDLE THORACIC INVOLVES THE RISK OF FRACTURE ON OSTEOPOROTIC SPINE ABOVE THE MOST RIGID INSTRUMENTATION (HERE PEDICULAR SCREW) CONCLUSIONS : THIS TYPE OF INSTRUMENTATION (JAZZ CLAW) DOES NOT SEEM TO BE THE DISLODGING CAUSE. IT SEEMS THAT THE UPPER LEVEL OF THE INSTRUMENTATION IN MIDDLE THORACIC SPINE WITH HARD MECHANICAL CONSTRAINTS, OSTEOPOROTIC AND POOR BONE QUALITY ARE THE CAUSES. IT WOULD HAVE BEEN BETTER TO FIX THE INSTRUMENTATION ON THE UPPER THORACIC SPINE. THIS WAS PERFORMED DURING THE SECOND SURGERY. THIS WAS THE BEST SOLUTION AND COULD HAVE BEEN PERFORMED ON THE FIRST INTENTION WITH JAZZ CLAW WITH LESS CONSTRAINTS ON THE BONES. DEVICE DISCARDED.

    Description of Event or Problem · 1

    IMPLANTABLE HARDWARE DISLODGED IN SITU DUE TO PATIENT PATHOLOGY PROGRESSION. PRODUCTS REMOVED DURING REVISION SURGERY 4 WEEKS POST SURGERY. ALTERNATIVE IMPLANTABLE USED TO REPLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414503 JAZZ SYSTEMS JAZZ CLAW HOOK OWI IMPLANET 150712 GNXF-FSTUR 03607503507127

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention