BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3072776 · Received April 23, 2013

    Report

    Report Number
    1030489-2013-01228
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    July 6, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT "MEDICALLY UNNECESSARY, EXPERIMENTAL" SPINE SURGERIES WHERE CERVICAL AND THORACIC RODS, SCREWS, CAGES AND RHBMP-2/ACS WERE IMPLANTED. THE PATIENT HAS SUSTAINED INJURY WITHIN THE PAST FOUR YEARS. THE PATIENT HAS ALLEGEDLY UNDERGONE RELATED FOLLOW UP CARE, PHYSICAL THERAPY, PRESCRIPTIONS, INJECTIONS, AND IMAGE STUDIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2008 OR 2009, THE PATIENT PRESENTED WITH WEAKNESS IN HIS LEFT LEG. THE SURGEON MADE THE PATIENT TO HAVE AN MRI DONE, AND AFTER THE MRI, DIAGNOSED THE PATIENT WITH THORACIC SPINAL STENOSIS T4-T5 TO T11-T12, AND THORACIC DISC DEGENERATION T4-T5 TO T11-T12. ON (B)(6) 2010, THE SURGEON PERFORMED SURGERY ON THE PATIENT, CONSISTING OF THORACIC ANTERIOR DISECTOMY T4-5, 5-6, 6-7, 7-8, 8-9, 9-10, 10-11, AND 11-12; ANTERIOR INTERBODY FUSION FROM T4-T5; PLACEMENT OF ANTERIOR INTERBODY CAGES FROM T4-T5 ALL THE WAY TO T11-T12; POSTERIOR SPINAL INSTRUMENTATION AND FUSION FROM T4 TO T11; AND THORACIC LAMINECTOMY T8-T9, T9-T10, T10-T11, T11-T12. RHBMP-2/ACS WAS USED DURING THIS SURGERY. FOLLOWING THE SURGERY, THE PATIENT WAS EXPERIENCING THE SAME PAIN HE EXPERIENCED PRIOR TO UNDERGOING SURGERY. THE PATIENT STILL SUFFERS BACK PAIN, WHICH HAS SEVERELY LIMITED HIS MOBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175477 UNKNOWN FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention