BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENGAL STACK STD LOR 24MM

    MDR report key: 6465058 · Received April 6, 2017

    Report

    Report Number
    1526439-2017-10234
    Event Type
    Malfunction
    Date Received
    April 6, 2017
    Date of Event
    March 13, 2017
    Report Date
    March 13, 2017
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MQP
    PMA / PMN Number
    K073649
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    MEDWATCH FORM SUBMITTED BY PATIENT (MW5068169). I HAD A FAILED CERVICAL CORPECTOMY PROCEDURE INVOLVING A CORPECTOMY SPINAL CAGE THAT IS NOT FDA APPROVED OR CLEARED FOR USE IN THE NECK. MEDICAL RECORDS SHOW THE DEVICE TO BE THE 24 MM TALL X 12 X 14 MM FOOTPRINT STANDARD LORDOTIC BENGAL STACKABLE MONOLITH. A DEPUY SYNTHES SALES REP WAS ALSO PRESENT DURING THE FAILED OPERATIVE PROCEDURE. WITHIN ONE WEEK, I WAS INFORMED THE PROCEDURE FAILED BUT WAS NEVER TOLD THE FAILURE WAS RELATED TO DEVICE SUBSIDENCE AND OR MIGRATION. I HAD TO UNDERGO POSTERIOR CERVICAL FUSION. I WAS NEVER INFORMED BY MY SURGEON, HOSPITAL REPRESENTATIVE OR DEVICE REPRESENTATIVE THAT THE SPINAL CORPECTOMY CAGE WAS NOT FDA APPROVED OR CLEARED FOR USE IN THE CERVICAL SPINE DESPITE THE CURATIVE POSTERIOR FUSION SURGERY. MY LEFT ARM AND HAND ARE WASTING AWAY. THE INSTRUCTIONS FOR USE AND MATERIALS ON THE DEPUY SYNTHES WEBSITE ADVERTISED THE BENGAL STACKABLE MONOLITH AS A SPINAL CAGE THAT DOCTORS ARE SUPPOSED TO IMPLANT THE DEVICE IN THE BACK BELOW LEVELS OF THE CERVICAL SPINE BUT THIS IS IMPOSSIBLE SINCE THE SPINAL CAGE IS TOO SMALL AND CONFIGURED TO FIT THE CURVATURE OF THE NECK. THE DEVICE LABELING IS COMPLETELY INADEQUATE AND PROVIDES MISLEADING INFORMATION ABOUT WHAT THE DEVICE IS DESIGNED TO ACTUALLY DO AND WHERE IT IS ACTUALLY SUPPOSED TO BE IMPLANTED. THOUGH IMAGING STUDIES SHOW THAT THE DEVICE WAS USED TO FILL THE VOID AT THE C6 VERTEBRAL BODY AND C5-6 AND C6-7 ADJACENT DISC SPACES THE PROCEDURE WAS BILLED AS A THREE LEVEL PARTIAL CERVICAL CORPECTOMY. I HAVE REPORTED THESE FINDINGS TO THE INSURANCE BENEFITS COMPANIES AS THE BILLING CPT CODES ARE NOT CONSISTENT WITH THE ACTUAL PROCEDURE PERFORMED OR THE IMAGING STUDIES. MY CONSENT FORM ALSO NEVER DISCLOSED THAT USE OF THE DEVICE WAS NOT FDA APPROVED IN THE NECK OR ANY OF THE COMPLICATIONS OR RISKS OF USING THE DEVICE OR IN THE EVENT OF DEVICE RELATED FAILURES IN THE NECK

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246535 BENGAL STACK STD LOR 24MM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R