BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC PRESTIGE ARTIFICIAL DISC

    MDR report key: 1712767 · Received June 2, 2010

    Report

    Report Number
    MW5016215
    Event Type
    Injury
    Date Received
    June 2, 2010
    Date of Event
    September 4, 2009
    Report Date
    June 2, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MJO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PRESTIGE ARTIFICIAL DISC -MEDTRONIC- IMPLANTED IN C6-7 IN (B) (6) -MEDTRONIC REP PRESENT-. PT HAD SEVERE - DESCRIBED AS HUGE- HERNIATION VENTRALLY EXTRUDED INTO SPINAL CORD CAUSING MYELOPATHY, DUE TO TRAUMA. PT ALSO HAD A CENTRAL MODERATE HERNIATION AT C5-6. AD WAS OFF CENTER DUE TO C5-6 HERNIATION CAUSING BALL AND TROUGH TO RISE AND BURST CENTRAL C5-6 INTO SPINAL CORD. ON (B) (6) 2010 DR THEN REMOVED DISC AT C6-7 AND FUSED WITH SPACER AND MEDTRONIC INFUSE CELL GROWTH PRODUCT AND PUT IN MEDTRONIC PRESTIGE CERVICAL DEVICE AT C5-6. I NOW HAVE "SIGNIFICANT SPINAL CORD INJURY TO MY LOWER NEURONS AS NOTED BY SEVERE ATROPHY". I HAVE LEFT (B) (6) BECAUSE OF A LACK OF MEDICAL CARE. NO DOCTOR WILL EVALUATE DUE TO DR PROFILE IN COMMUNITY. I AM NOW IN (B) (6) IN THE PROCESS OF EVAL AT (B) (6) IF ACCEPTED. I HAVE ALREADY BEEN DENIED BY A DR (B) (6) -(B) (6)- "DUE TO LIABILITY FACTOR" I HAVE HAD 2-3 CT AND 2-3 MRI. TWO NEUROLOGIST AND 2 NEUROSURGEONS STATED THAT I MUST HAVE THE DEVICE REMOVED. REASONING IS THAT I WILL SUFFER FURTHER PARALYSIS . THE MEDICAL ESTABLISHMENT IS NOT WILLING OR ABLE TO RISK INVOLVEMENT DUE TO THE FDA AND MEDTRONIC OVER SITE -POSSIBLE CONTROVERSY-. THE DEVICE IS ON PRELIMINARY APPROVAL STATUS SINCE 2007 AND MUST BE STUDIED FOR THE FOLLOWING 7 YEARS FOR FINAL APPROVAL. THERE IS ONLY SMALL POPULATION OF SURGEONS TRAINED BY MEDTRONIC ON THIS DEVICE AND I WOULD GUESS EVEN LESS TRAINED IN THE REMOVAL OF A DEVICE IN A PRECARIOUS SITUATION. THE SPINAL CORD DAMAGE EXTENDS FROM MY JAW TO THE T2-3 REGION AND MY HEALTH IS DETERIORATING AT A PROGRESSIVE LEVEL. I WAS IN THE ER ON THE NIGHT OF (B) (6) 2010 AND TOLD I NEED TO BE SEEN AT A HIGH LEVEL FACILITY. I HAVE HAD NO SUCCESS DUE TO MD AVERSION TO NEW DEVICE AND MEDTRONIC CONTRACTS. IF THIS PRODUCT IS APPROVED FOR INSERTION INTO THE CERVICAL SPINE, IT MUST BE ABLE TO BE REMOVED IF IT IS IMPINGING AN ALREADY DAMAGED SPINAL CORD. I HAVE A WIFE AND TWO CHILDREN WITH LIMITED FINANCES. I AM BARELY AMBULATORY AND AT RISK OF MORE SEVERE COMPLICATIONS INCLUDING DEATH. A LACK OF POPULATION OF SURGEONS ABLE OR WILLING TO WORK WITH THIS PRODUCT UNIQUE CHARACTERISTICS. INTRODUCED 2007 CONTINGENT UPON 7 YEAR FOLLOW UP STUDY. MY MEDICAL CONDITION IS AN EMERGENT CASE. DIAGNOSIS OR REASON FOR USE: MYELOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC PRESTIGE ARTIFICIAL DISC CERVICAL ARTHROPLASTY MJO MEDTRONIC SOFAMOR DANEK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| L| O| R| S STUDY. MY MEDICAL CONDITION IS AN EMERGENT CASE.| TO WORK WITH THIS PRODUCT UNIQUE CHARACTERISTICS.| A LACK OF POPULATION OF SURGEONS ABLE OR WILLING| INTRODUCED 2007 CONTINGENT UPON 7 YEAR FOLLOW UP