BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3072769 · Received April 23, 2013

    Report

    Report Number
    1030489-2013-01227
    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 POST-OPERATIVE PERIOD WAS MARKED BY SEVERE PAIN. IMAGING STUDIES ULTIMATELY SHOWED THAT THE PATIENT DEVELOPED UNCONTROLLED BONE GROWTH AND RESULTING NERVE IMPINGEMENT AT OR NEAR THE IMPLANT SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN 2008, THE PATIENT, A MINOR, WAS SUGGESTED TO FOLLOW-UP WITH AN ORTHOPAEDIC PHYSICIAN AFTER A SCOLIOSIS SCREENING. AT THE TIME OF THE SCREENING, THE PATIENT WAS NOT EXPERIENCING ANY PAIN OR OTHER ISSUES WITH HER BACK. ON (B)(6) 2008, SHE UNDERWENT X-RAYS AND MRI WHICH REVEALED THAT HER BACK WAS AT A 29 DEGREE CURVATURE OF HER SPINE TO THE RIGHT. THE PATIENT REMAINED IN THE BODY CAST FOR THE NEXT SIX MONTHS, AS SUGGESTED BY THE SURGEON. THE PATIENT UNDERWENT SECOND MRI WHICH REVEALED 39 DEGREE CURVATURE OF HER SPINE TO THE RIGHT. ON (B)(6) 2008, THE PATIENT UNDERWENT SPINAL SURGERY. THE PATIENT WAS IMPLANTED WITH RHBMP-2/ACS. POST-OP, SHE BEGAN EXPERIENCING EXTREME PAIN, WHERE SHE EXPERIENCED NO PAIN PRIOR TO THE SURGERY. IN (B)(6) 2008, THE PATIENT PRESENTED FOR THE FIRST FOLLOW-UP VISIT. THE PATIENT IS NOW PERMANENTLY DISFIGURED, HARMED, IMMOBILE, AND IN CONSTANT PAIN. HER CONDITION IS EMBARRASSING, EMOTIONALLY DRAINING, AND CONSTANTLY PAINFUL. THE PATIENT IS CURRENTLY (B)(6), AND IS IMMOBILE, UNABLE TO PUSH HERSELF UP, NO LONGER HAS NECK MOBILITY, AND IS COMPLETELY DIFFERENT THAN PRIOR TO THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173531 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 Other| R