BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2862350 · Received December 10, 2012

    Report

    Report Number
    1030489-2012-02711
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    March 20, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 PRESENTED WITH DEGENERATIVE JOINT DISEASE AT L4-5 AND L5-S1. THE PATIENT UNDERWENT A MINIMALLY INVASIVE TLIF USING LOCAL BONE AUTOGRAFT, RHBMP-2/ACS, INTERBODY DEVICES, AND POSTERIOR PEDICLE SCREW INSTRUMENTATION. THERE WERE NO NOTED COMPLICATIONS. (B)(6) DAYS POST-OP, THE PATIENT PRESENTED FOR AN OFFICE VISIT. PER THE PHYSICIAN'S NOTES, "HE CONTINUES TO HAVE LEFT GREATER THAN RIGHT LEG PAIN THAT IS ATYPICAL. HE HAS VERY LITTLE LOW BACK PAIN" HE HAS A SOLID FUSION FROM L4 TO S1, HOWEVER, THERE APPEARS TO BE SOME SIGNIFICANT NEURAL FORAMINAL NARROWING AT THE L4-5 LEVEL ON THE LEFT GREATER THAN THE RIGHT. "THE PATIENT HAS A BONY GROWTH WITHIN THE CANAL AND THE NEURAL FORAMEN, ESPECIALLY ON THE LEFT-HAND SIDE." (B)(6) DAYS POST-OP, A (B)(4) STUDY INDICATED "ACUTE DENERVATION CHANGES SEEN ON NEEDLE EMG EXAMINATION SUGGESTING ACUTE LEFT L4 L5 RADICULOPATHY. CHRONIC DENERVATION CHANGES SEEN ON NEEDLE EMG EXAMINATION SUGGESTING A CHRONIC POLYRADICULOPATHY BILATERALLY FROM L4-S1. NORMAL NERVE CONDUCTION STUDIES". (B)(6) DAYS POST-OP, THE PATIENT PRESENTED FOR AN OFFICE VISIT. THE PATIENT PRESENTED WITH BAD LEFT LEG RADICULOPATHY, BUT NO LOW BACK PAIN. A TRANSFORAMINAL INJECTION WAS RECOMMENDED. (B)(6) DAYS POST-OP, THE PATIENT RETURNED FOR FOLLOW UP. THE PATIENT HAD NOT GOTTEN THE TRANSFORAMINAL INJECTION. SURGERY WAS DISCUSSED. (B)(6) DAYS POST-OP, THE PATIENT PRESENTED WITH "TERRIBLE 10/10 LEG PAIN". SURGERY WAS DISCUSSED. (B)(6) DAYS POST-OP, THE PATIENT UNDERWENT EXPLORATION OF THE FUSION AT L4-5 AND L5-S1 WITH TRANSPEDICULAR DECOMPRESSION OF THE EXITING AND TRAVERSING NERVE ROOTS. PER THE OPERATIVE NOTES, "A SEVERE AMOUNT OF BONY STENOSIS WAS ENCOUNTERED. FORAMINOTOMIES WERE PERFORMED AS WELL AND THE EXITING AND TRAVERSING NERVE ROOTS AND BOTH LEVELS WERE FULLY DECOMPRESSED AND SKELETONIZED". THERE WAS AN INCIDENTAL DURAL TEAR WHICH WAS REPAIRED INTRAOPERATIVELY WITH TISSEAL AND SHOWN NOT TO BE LEAKING. (B)(6) DAYS POST-OP, THE PATIENT PRESENTED FOR A POST-OP VISIT. PER THE PHYSICIAN'S NOTES, THE PATIENT HAS A PSEUDOMENINGOCELE, "HE IS SO SKINNY THAT HE DOES NOT HAVE MUCH PADDING TO TAMPONADE THE SMALL DUROTOMY. IN ADDITION HE SMOKES WHICH WILL SLOW DOWN HIS WOUND HEALING. HE IS HAVING MINOR HEADACHES, ESPECIALLY WHEN HE IS UP. HE SAYS THEY GO AWAY WHEN HE LAYS DOWN". (B)(6) DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP. PER THE PHYSICIAN'S NOTES, "THE SURGERY WENT FINE AND HE NO LONGER HAS LEG PAIN. "HE HAS A PSEUDOMENINGOCELE WITH A NOTICEABLE COLLECTION OF FLUID UNDERNEATH HIS INCISION, WHICH IS SOFT WITH PALPATION. THERE IS NO LEAKAGE OUTSIDE THE WOUND. HE HAS BEEN HAVING SPINAL HEADACHES". (B)(6) DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP. HE HAS HAD 2 BLOOD PATCHES PER THE SPINAL FLUID LEAK, AND THEY ARE NOT WORKING. HE CONTINUES TO HAVE SPINAL HEADACHES. (B)(6) DAYS POST-OP, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO TREAT THE PSEUDOMENINGOCELE. A LUMBAR DRAIN WAS PLACED. THERE WERE NO NOTED COMPLICATIONS. (B)(6)DAYS POST-OP, THE PATIENT RETURNED FOR A POST-OP VISIT. THERE WERE NO NOTED COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION AT LEVELS L4-L5, L5-S1 IN WHICH RHBMP-2/ACS WAS USED. THE PATIENT'S POST-OPERATIVE PERIOD WAS REPORTEDLY MARKED BY INCREASINGLY SEVERE PAIN IN HIS BACK AND BOTH OF HIS LEGS. POST-OPERATIVE IMAGING STUDIES ALLEGEDLY REVEALED THAT THE PATIENT HAD DEVELOPED UNCONTROLLED BONE GROWTH ("BONE OVERGROWTH") AND RESULTING NERVE COMPRESSION AND SEVERE RADICULOPATHY RELATED TO BONE OVERGROWTH AT OR NEAR THE IMPLANT SITE. THE PATIENT WAS FORCED TO UNDERGO A PAINFUL REVISION SURGERY AT LEVELS L4-5, L5-S1, DURING WHICH "SEVERE AMOUNTS[S] OF BONE GROWTH" CAUSING "SEVERE STENOSIS OF THE EXISTING AND TRANSVERSING NERVE ROOTS ON THE LEFT AT L4-5 AND L5-S1" WERE FOUND. POST-OP, THE PATIENT WAS FORCED TO UNDERGO YET ANOTHER SURGERY, THIS TIME TO REPAIR AN INCIDENTAL DUROTOMY THAT OCCURRED DURING THE PREVIOUS REVISION SURGERY. THE PATIENT NOW SUFFERS FROM SEVERE INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO BONE OVERGROWTH CAUSING CHRONIC PAIN. THE PATIENT CAN REPORTEDLY NO LONGER LIFT HEAVY OBJECTS AND HAS CHRONIC PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 Required Intervention