BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2991136 · Received March 6, 2013

    Report

    Report Number
    1030489-2013-00683
    Event Type
    Injury
    Date Received
    March 6, 2013
    Report Date
    October 17, 2016
    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
    PATIENT

    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. 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

    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 THAT THE PATIENT UNDERWENT AN UNSPECIFIED SPINAL SURGERY USING RHBMP-2/ACS. POST-OP, THE PATIENT DEVELOPED "SIGNIFICANT PAIN-AS WELL AS REQUIRED ME TO UNDERGO A REVISION SURGERY, I'M WORRIED THINGS WILL GET WORSE." ADDITIONALLY, THE PATIENT HAS REPORTEDLY "HAD MANY PROBLEMS ... INCLUDING PAIN, MENTAL ANGUISH, PHYSICAL LIMITATIONS, AS WELL AS REQUIRED ME TO UNDER GO ADD'L SURGERIES."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011, PATIENT UNDERWENT FOLLOWING PROCEDURE: ANTERIOR SPINAL FUSION, L3-L4, L4-L5, L5-S1. INTERBODY CAGE, L4-L5, L5-S1. BONE MORPHOGENETIC PROTEIN PRE-OP AND POST-OP DIAGNOSIS: ADULT KYPHOSCOLIOSIS, STENOSIS, MULTILEVEL DEGENERATIVE DISC DISEASE. AS PEROP NOTES: ".. AT L5-S1, A CAGE OF MEDIUM FOOTPRINT, A 15 DEGREE ANGLE WAS CHOSEN. AFTER THE ENDPLATE WAS THREADED DOWN THE SUBCHONDRAL BONE, THE CAGE WAS PACKED WITH BMP 2, WRAPPED AROUND ALLOGRAFT AND IMPACTED INTO DISK SPACE, CORRECTING THE ANGULATION. THE SAME MANEUVER PERFORMED AT L4-L5, AGAIN WITH REFLECTION OF THE ANNULUS, DISCECTOMY AND CURETTAGE, OSTEOPHYTE RELEASE, AND ELEVATION OF THE DISK SPACE. AGAIN, A 15-DEGREE CAGE WAS PLACED ASYMMETRICALLY TO CORRECT THE DEFORMITY. AT L3-L4, WHICH WAS ALSO SEVERELY ANGLED, AN OSTEOTOME WAS USED TO MOBILIZE THE DISK SPACE AND TO RESECT PORTIONS OF THE END PLATE OF L3 TO CREATE FULL MOBILITY. CARTILAGE WAS AGAIN REMOVED DOWN TO THE SUBCHONDRAL BONE. AT THIS LEVEL, A SINGLE BMP SOAKED SPONGE WRAPPED AROUND THE ALLOGRAFT WAS PLACED INTO THE DISK SPACE, FOLLOWED BY LOOSE ALLOGRAFT.. THE PATIENT WAS DEEMED STABLE FOR POSTERIOR FUSION.." PATIENT ALLEGES UNSPECIFIED INJURY DUE TO THE USE OF RHBMP-2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96324 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 60 YR Required Intervention