BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 5024297 · Received August 24, 2015

    Report

    Report Number
    1030489-2015-02051
    Event Type
    Injury
    Date Received
    August 24, 2015
    Report Date
    July 27, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER, THEREFORE, CAUSE OF EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2012: THE PATIENT PRESENTED WITH COMPLAINT OF RIGHT CALF NUMBNESS AND SEVERE BACK PAIN AND SOME LEFT GROIN PAIN ONLY WITH WALKING. THE BACK PAIN AS WELL AS BILATERAL BUTTOCK NUMBNESS CONTINUED TO BE QUITE DISABLING AND UNCOMFORTABLE. ASSESSMENT: 1. CHRONIC INTRACTABLE LOWER BACK PAIN AND BILATERAL BUTTOCK NUMBNESS AND POSTERIOR THIGH NUMBNESS, GENITALIA NUMBNESS. 2. SIGNIFICANT INSTABILITY AT L5-S1 WITH LYTIC SPONDYLOLISTHESIS AT L5-S1 WITH ABOUT 5 MM OF MOTION AT L5-S1. 3. SEVERE L5 FORAMINAL STENOSIS MOST LIKELY THE CAUSE OF BUTTOCK PAIN AND NUMBNESS. 4. L4-5 INSTABILITY WITH ABOUT 4 MM OF MOTION FROM FLEX ION-EXTENSION X-RAYS. ON (B)(6) 2012: THE PATIENT PRESENTED WITH THE FOLLOWING PREOPERATIVE DIAGNOSES: 1. GRADE L1/2 LYTIC SPONDYLOLISTHESIS AT L5-S1. 2. INSTABILITY OF L4-L5 RETROLISTHESIS 4 MM OF MOTION WITH SEVERE CANAL STENOSIS AT L4-L5 AS WELL AS L5-S1. 3. SIGNIFICANT INSTABILITY AT L5-S1 AS WELL AS IMMOBILITY AT L4-L5. THE FOLLOWING PROCEDURES WERE PERFORMED: 1. L4 ANTERIOR OSTEOTOMY AS WELL AS L5 ANTERIOR OSTEOTOMY. 2. PLACEMENT OF PEEK INTERBODY GRAFT, L4-L5, SIZE 19, 8-DEGREE LORDOSIS. 3. ANTERIOR LUMBAR INTERBODY FUSION, L4- L5 AND L5-S1 USING ALLOGRAFT BONE DBM INFUSED. 4. OPEN REDUCTION OF L5-S1 SPONDYLOLISTHESIS AS WELL AS L4-L5 RETROLISTHESIS. 5. ANTERIOR INSTRUMENTATION OF L4-L5 USING 25-MM SCREWS. 6. L5 AS WELL AS S1 ANTERIOR OSTEOTOMY. 7. PLACEMENT OF PEEK INTERBODY GRAFT, SIZE 19. L5-S1 8. ANTERIOR INSTRUMENTATION OF L5-S1 USING 25-MM SCREWS, SPINAL USA, ALL THE INSTRUMENTATION ARE SPINAL USA. 9. USE OF ALLOGRAFT BONE, DBM X2. 10. USE OF FLUOROSCOPY. 11. USE OF SSEP AND TRIGGERED EMGS. RH-BMP2/ACS WAS IMPLANTED ON THE PATIENT. ALLOGRAFT DBM, PEEK INTERBODY GRAFT, PEEK INTERBODY CAGE AND CANNULATED SCREWS WERE USED. THE PATIENT ALSO UNDERWENT X-RAY DURING LUMBAR DISCECTOMY AT L4-S1 ALIF, L4-S1 PSFI. IMPRESSION: INTRAOPERATIVE FLUOROSCOPY PROVIDED FOR PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLICATIONS WERE REPORTED. ON (B)(6) 2012: THE PATIENT UNDERWENT X-RAY OF LUMBOSACRAL SPINE, POST-OP. ON (B)(6) 2012: THE PATIENT UNDERWENT COLOR DOPPLER AND DUPLEX IMAGING OF THE LOWER EXTREMITIES DUE TO PAIN R/O DEEP VEIN THROMBOSIS. IMPRESSION: NEGATIVE. NO DEEP VEIN THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557261 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M111109AAC

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Other