BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3072060 · Received April 22, 2013

    Report

    Report Number
    1030489-2013-01191
    Event Type
    Injury
    Date Received
    April 22, 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

    BRAND NAME: UNKNOWN HARDWARE, INFUSE BONE GRAFT. (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 WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT AND WAS INITIALLY DIAGNOSED WITH NECK STRAIN. THE PATIENT UNDERWENT AN MRI THAT REVEALED A BROKEN BONE WAS FOUND AS WELL AS CYST ON HER VERTEBRA AT T6/ T7. PATIENT UNDERWENT A C4/C5 FUSION WITH RHBMP-2/ACS ON (B)(6) 2007 TO RESOLVE HER NECK ISSUES. POST-OP, THE NECK PAIN WAS RESOLVED. AGAIN THE PATIENT UNDERWENT ANOTHER SURGERY IN (B)(6) 2008, THE CYST WAS REMOVED THAT WAS IDENTIFIED IN AN MRI SCAN. FOLLOWING THE SURGERY, MID- BACK PAIN PERSISTED. PATIENT UNDERWENT A SURGERY IMPLANTING A ROD AND SIX SCREWS. POST-OP, PATIENT HAD FOUR SCARS ON HER BACK, A SEVEN INCH SCAR, AND FOUND THAT HER BACK WAS INDENTED IN THE REGION WHERE THE SEVEN INCH SCAR LIES. HER PAIN WAS EXTREME AND SHE SUFFERED FROM DIFFICULTY IN BREATHING. PATIENT CONTINUED TO SUFFER FROM EXTREME PAIN AND DISCOMFORT. ALSO THE PATIENT COULD NO LONGER SLEEP DUE TO THE ROD IN HER BACK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL FUSION FROM T6-T8 USING RHBMP-2/ACS ON (B)(6) 2009. THE PATIENT REPORTEDLY SUSTAINED UNSPECIFIED INJURIES FOLLOWING IMPLANTATION OF RHBMP-2/ACS AND HAD TO UNDERGO A REVISION SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171822 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