BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2872349 · Received December 13, 2012

    Report

    Report Number
    1030489-2012-02799
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    March 27, 2014
    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)(4)

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). 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 LOW BACK PAIN, BUTTOCK PAIN, AND LEFT LEG PAIN. THE PATIENT WAS DIAGNOSED WITH CHRONIC LOW BACK PAIN WITH HISTORY OF L4-5 DISCECTOMY WITH WORSENING OF HER PAIN OVER THE LAST 6 MONTHS, AND RADICULOPATHY. MRI OF THE LUMBAR SPINE WAS REVIEWED AND SHOWED EVIDENCE OF RECURRENT DISK HERNIATION AT L4-5. THE PATIENT PRESENTED WITH L4-5 RECURRENCE OF DISK HERNIATION, LOW BACK PAIN, LEFT-SIDED SCIATICA, AND FAILURE OF CONSERVATIVE TREATMENT. THE PATIENT UNDERWENT A MINIMALLY INVASIVE LEFT-SIDED POSTERIOR FUSION USING VIPER II HARDWARE, CONDUIT BONE GRAFT EXTENDER, AND RHBMP-2/ACS. THERE WERE NO NOTED COMPLICATIONS. (B)(4) DAYS POST-OP, THE PATIENT PRESENTED WITH LEFT LEG NUMBNESS TO THE FOOT. AN MRI OF THE LUMBAR SPINE INDICATED "L4 AND L5 LEVELS WITH INTERVERTEBRAL DEVICE. RESIDUAL/RECURRENT DISC MATERIAL IS NOTED WITHIN THE CENTRAL, BILATERAL PARACENTRAL REGION EXTENDING SUPERIOR TO THE DISC SPACE LEVEL". (B)(4) DAYS POST-OP THE PATIENT PRESENTED FOR NEUROLOGICAL EXAM. PER THE PHYSICIAN'S NOTES, "RESIDUAL LUMBAR RADICULOPATHY ON THE LEFT". (B)(4) DAYS POST-OP A CT SCAN INDICATED "PRIOR FUSION AT L4-5. THE HARDWARE APPEARS INTACT. THERE IS EVIDENCE OF PRIOR L4-5 DISCECTOMY WITH INTERBODY FUSION. THERE IS NO ACUTE FRACTURE. - THERE IS PROMINENT FACET ARTHROPATHY WITH MILD CANAL AND FORAMINAL NARROWING". (B)(4) DAYS POST-OP, AN MRI OF THE LUMBAR SPINE INDICATED "POSTOPERATIVE CHANGE OF THE LUMBAR SPINE. NO DISC HERNIATION, OTHER EPIDURAL MASS LESION OR SPINAL STENOSIS. MODERATELY SEVERE FACET ARTHRITIS. - EVIDENCE OF PRIOR FUSION AT L4-5. NEGATIVE FOR DEFINITE LUMBAR SPINAL FRACTURE OR LIGAMENTOUS DISRUPTION".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2008, THAT PATIENT UNDERWENT TLIF AT L4-L5 USING RHBMP-2/ACS. SOMETIME POSTOP, THE PATIENT DEVELOPED WORSENING NERVE PAIN AND WEAKNESS HER LEGS, WHICH HAS CAUSED INSTABILITY, BALANCE PROBLEMS, AND FALLS. SUBSEQUENT IMAGING STUDIES ULTIMATELY SHOWED PATIENT SUFFERED FROM IMPINGEMENT DUE TO BONE OVERGROWTH AT THE OPERATIVE LEVEL.THE PATIENT NOW REPORTEDLY HAS HETEROTOPIC OSSIFICATION, PAIN, AND NEUROPATHY.

    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 M110703AAF

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention