BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3163385 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02211
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    November 28, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NON-MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT A PROCEDURE FOR L4-L5, L5-S1 POSTERIOR AND POSTEROLATERAL FUSION WHERE RHBMP-2 WAS MIXED WITH ALLOGRAFT AND PLACED AT MULTIPLE LEVELS OF THE SPINE. SUBSEQUENTLY, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, ON (B)(6) 2010, PATIENT UNDERWENT FOLLOWING PROCEDURE: L4-5 AND L5-S1 BILATERAL HEMILAMINECTOMIES, MEDIAL FACETECTOMIES, FORAMINOTOMIES, DORSAL DECOMPRESSION OF THE THECAL SAC AND NERVE ROOTS SECONDARY TO LIGAMENTUM FLAVUM HYPERTROPHY AND FACET ARTHROPATHY. L4-5 AND L5-S1 BILATERAL VENTRAL DECOMPRESSION OF THE THECAL SAC AND NERVE ROOTS SECONDARY TO DISK BULGING AND OSTEOPHYTIC RIDGING. L4-5 AND L5-S1 BILATERAL POSTERIOR LUMBAR INTERBODY FUSION WITH MILLED ALLOGRAFT TRICORTICAL BONE DOWEL AND HUMAN BONE MORPHOGENETIC PROTEIN. L4-5 AND L5-S1 TRANSARTICULAR SCREW FIXATION. L4, L5 AND S1 POSTEROLATERAL FUSION USING HUMAN BONE MORPHOGENETIC PROTEIN AND LOCAL HARVEST OF AUTOGRAFT BONE. 6L4, L5 AND S1 MEDIAL BRANCH RHIZECTOMIES FOR RELIEF OF FACETOGENIC BACK PAIN SECONDARY TO SPONDYLOSIS. PRE-OP AND POST-OP DIAGNOSIS: L4-5 AND L5-S1 DEGENERATIVE DISK DISEASE. MECHANICAL LOW BACK PAIN. LUMBOSACRAL RADICULOPATHY. PER OPERATIVE NOTES: ".. THECAL SAC AND NERVE ROOTS WERE COMPLETELY DECOMPRESSED DORSAL AND VENTRALLY. LNTERBODY BONE WAS IN EXCELLENT POSITION VISUALLY .. HUMAN BONE MORPHOGENETIC PROTEIN WAS USED TO FILL THE REMAINING INTERBODY SPACES AT L4-5 AND L5-S1. BILATERAL TRANSARTICULAR FACET SCREWS WERE PLACED TO REDUCE THE DIASTASIS OF THE FACET COMPLEXES BILATERALLY WITH GOOD REDUCTION OF THE DIASTASIS.. X-RAY EXAMINATION WAS USED TO CONFIRM PLACEMENT OF TRANSARTICULAR SCREWS AT 4-5 AND 5-1 AS WELL AS THE INTERBODY BONE.. PATIENT AWAKENED FROM GENERAL ENDOTRACHEAL ANESTHESIA WITHOUT COMPLICATION AND TAKEN TO THE RECOVERY ROOM WHERE HE REMAINED NEUROLOGICALLY INTACT AND STABLE THROUGHOUT.."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264176 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110811AAC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention