BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3072754 · Received April 23, 2013

    Report

    Report Number
    1030489-2013-01223
    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)

    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 THE PATIENT UNDERWENT A POSTERIOR INSTRUMENTED SURGERY FUSING C2-T9 WHERE RHBMP-2/ACS WAS USED ON (B)(6)-2011. SCREWS WERE PLACED AT C2,C3,C5,T8, AND T9. PRE OPERATIVE IMAGES SHOWED SCOLIOSIS WAS PRESENT FROM C6-T6. THE PATIENT REPORTEDLY SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE IMPLANTATION OF RHBMP-2/ACS. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON UNKNOWN DATE ,THE PATIENT WAS EXPERIENCING PROBLEMS WITH HER NECK AND BACK. IN (B)(6) OF 2011, THE SURGEON PERFORMED THE UNSPECIFIED SURGERY AND RHMBP-2/ACS WAS IMPLANTED. AFTER THE SURGERY, THE PATIENT BEGAN TO SUFFER NUMBNESS THROUGH HER BODY. THE SURGEON INFORMED HER THAT THE NUMBNESS SHE WAS FEELING WOULD PASS WITHIN SIX TO NINE MONTHS. AS A RESULT OF THE COMPREHENSIVE NUMBNESS THAT THE PATIENT CONTINUES TO SUFFER, SHE HAS BEEN UNABLE TO ENJOY THE FREEDOM OF MOVEMENT AND PREVIOUS GOOD HEALTH THAT SHE HAD PRIOR TO HER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174639 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