BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BENGAL STACK STD LOR 30MM

    MDR report key: 6584270 · Received May 23, 2017

    Report

    Report Number
    1526439-2017-10386
    Event Type
    Injury
    Date Received
    May 23, 2017
    Date of Event
    June 10, 2013
    Report Date
    April 25, 2017
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MQP
    PMA / PMN Number
    K073649
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    VOLUNTARY MEDWATCH RECEIVED FROM FDA (MW5068871). IN 2013, SURGEON PERFORMED ANTERIOR CERVICAL CORPECTOMY USING THE BENGAL MONOLITH STACKABLE CAGE. THE CARBON-FIBER CORPECTOMY CAGE IS NOT FDA APPROVED OR CLEARED BY THE FDA FOR USE IN THE NECK. THE DEVICE IS IN DESIGN CONSTRUCT CONSISTS OF A FOOTPRINT OF 12X14MM AND HEIGHT OF 30MM AND WAS EXPLICITLY CLEARED FOR USE IN BACK (T1-L5) NOT IN THE NECK. THE LABELING DOES NOT DISCLOSE ANY SAFETY/RISK PROFILE FOR USE IN THE CERVICAL SPINE. MY SYMPTOMS INITIALLY IMPROVED BUT HAVE BEEN EXPERIENCING WORSENING PAIN IN MY HANDS, SHOULDERS. POST-OPERATIVE IMAGING STUDIES APPEAR TO SHOW THE DEVICE POSITIONING UPSIDE DOWN FROM ITS NORMAL ORIENTATION AND ALSO WITH CLINICALLY SIGNIFICANT SUBSIDENCE OR "PISTONING" INTO THE ADJACENT VERTEBRA. THE SURGEON DID NOT DISCLOSE FINANCIAL TIES TO THE DEVICE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365993 BENGAL STACK STD LOR 30MM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R