BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3923671 · Received July 9, 2014

    Report

    Report Number
    1030489-2014-03174
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A FUSION PROCEDURE USING RHBMP-2/ACS IN NOVEMBER OF 2012. IT WAS REPORTED THAT THE PATIENT BEGAN EXPERIENCING PAIN IN HER NECK IN SPRING OF 2012. IN JUNE OF 2012, THE PATIENT DEVELOPED NUMBNESS ON THE RIGHT SIDE OF HER BODY AS WELL AS A SHOOTING PAIN INTO HER RIGHT SHOULDER AND ARM. THE DOCTOR DIAGNOSED THE PATIENT WITH TWO HERNIATED DISCS AT C3 THROUGH C5 AND SCHEDULED HER FOR A C5-C6 AND C6-C7 FUSION SURGERY. ON OR ABOUT (B)(6) 2012, THE DOCTOR PERFORMED THE CERVICAL FUSION SURGERY. IMMEDIATELY FOLLOWING THE SURGERY THE PATIENT FELT SOME RELIEF BUT STILL EXPERIENCED NUMBNESS IN HER RIGHT HAND THAT WAS PROGRESSIVELY WORSENING. SHE ALSO BEGAN TO EXPERIENCE INCREASED LOWER BACK PAIN. AFTER THE PATIENT'S 2012 APPOINTMENT THE PLAINTIFF DEVELOPED AND WAS DIAGNOSED WITH (B)(6). DURING HER APPOINTMENT THE DOCTOR'S DOG WAS PRESENT AND IT WAS BELIEVED THE DOG HAD (B)(6). A SECOND SURGERY WAS SCHEDULED EVEN THOUGH THE PATIENT'S PRE-OPERATIVE MRI INDICATED NO RADICULOPATHY. IN (B)(6) OF 2012 THE DOCTOR PERFORMED THE L4-L5 AND L5-S1 SPINAL FUSION SURGERY ON THE PATIENT. REPORTEDLY, THE PATIENT EXPERIENCES EXTREME PAIN AROUND THE LUMBAR INCISION AREAS WITH PAIN RADIATING OUTWARD FROM THE SURGICAL SITE. REPORTEDLY, THE PATIENT ADDITIONALLY EXPERIENCES CONSTANT NUMBNESS IN HER LEFT AND RIGHT HANDS. THE NUMBNESS IN HER RIGHT HAND HAS LEFT HER WITH LITTLE TO NO ABILITY TO CONTROL HER RIGHT HAND AND SHE IS NO LONGER ABLE TO WRITE. REPORTEDLY, THE PATIENT ALSO EXPERIENCES NECK AND SHOULDER PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399288 INFUSE BONE GRAFT 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