BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4460420 · Received January 28, 2015

    Report

    Report Number
    1030489-2015-00202
    Event Type
    Injury
    Date Received
    January 28, 2015
    Report Date
    January 18, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: CAGE, BONE MATRIX, ALLOGRAFT, AUTOGRAFT, PEDICLE SCREWS (IMPLANT (B)(6) 2013). (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING STUDY FILMS 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/USED 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

    (B)(4). 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 ON, (B)(6) 2015 THE PATIENT WAS PRESENTED FOR OFFICE VISIT. DIAGNOSIS: LUMBOSACRAL SPONDYLOSIS AND CHRONIC INSOMNIA. ON (B)(6) 2015, (B)(6) 2016 THE PATIENT WAS PRESENTED FOR OFFICE VISIT. DIAGNOSIS: LUMBOSACRAL SPONDYLOSIS AND COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016: THE PATIENT PRESENTED FOR AN OFFICE VISIT FOR PAIN MANAGEMENT FOR BACK PAIN. ON (B)(6) 2016: PATIENT WAS PRESENTED FOR OFFICE VISIT. DIAGNOSIS: SPONDYLOSIS WITHOUT MYELOPATHY, VITAMIN D DEFICIENCY. ON (B)(6) 2016: PATIENT WAS PRESENTED FOR OFFICE VISIT. DIAGNOSIS: OTHER SPONDYLOSIS WITH ¿MYE,¿ SIMPLE CHRONIC. ON (B)(6) 2016: PATIENT WAS PRESENTED FOR OFFICE VISIT. DIAGNOSIS: RADICULOPATHY LUMBAR REGION, ARTHRODESIS STATUS. ON (B)(6) 2016: THE PATIENT UNDERWENT CT OF LUMBAR SPINE DUE TO RADICULOPATHY. IMPRESSION: EXTENSIVE POSTSURGICAL CHANGES OF THE LUMBAR SPINE. NO ACUTE PRESSURE IS SEEN. MILD DEXTROSCOLIOSIS. POSSIBLE MILD RIGHT FORAMINAL DISC PROTRUSION AT THE L2-L3 LEVEL AND DIFFUSE DISC BULGE AT THE L3-L4 LEVEL. NO OTHER FOCAL DISC PROTRUSIONS OR EXTRUSIONS ARE SEEN. ON (B)(6) 2016: PATIENT WAS PRESENTED FOR OFFICE VISIT. DIAGNOSIS: OTHER SPONDYLOSIS WITH ¿MYE.¿ ON (B)(6) 2017: THE PATIENT PRESENTED FOR AN OFFICE VISIT FOR PAIN MANAGEMENT FOR BACK PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSES OF LUMBAR DEGENERATIVE SCOLIOSIS; LUMBAR SPONDYLOSIS; LUMBAR FORAMINAL STENOSIS. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: STAGE 1: ANTERIOR LUMBAR INTERBODY FUSION; STAGE 2: REMOVAL OF POSTERIOR INSTRUMENTATION; L3-L4, L5-S1 LAMINECTOMIES WITH BILATERAL L4 AND S1 FORAMINOTOMIES; L3-L4, L5-S1 POSTEROLATERAL FUSION WITH POSTERIOR INSTRUMENTATION USING THE K2M SYSTEM. A K2M LORDOTIC GRAFT WAS SIZED TO THE L5-S1 DISC SPACE. IT WAS PACKED WITH BONE MORPHOGENIC PROTEIN AND ALLOGRAFT BONE UNTIL IT WAS FLUSHED WITH THE L5 AND S1 VERTEBRA. THIS CAGE WAS MADE OUT OF PEEK. TWO SCREWS WERE PLACED THROUGH THE SCREW SLOTS INTO THE SACRUM AND ONE SCREW UP INTO THE L5 VERTEBRAL BODY. THE SCREWS WERE FINALLY TIGHTENED. BONE MORPHOGENIC PROTEIN, DEMINERALIZED BONE MATRIX, ALLOGRAFT BONE AND THE PATIENT¿S AUTOGRAFT GRAFT BONE WAS LAID THAT HAD BEEN COLLECTED THROUGHOUT THE PROCEDURE OVERLYING THE L3-L4 LEVEL AND THE L5-S1 LEVEL IN ORDER TO INDUCE A POSTEROLATERAL FUSION. AT THIS POINT NEW PEDICLE SCREWS WERE PLACED AT L3 BILATERALLY USING THE METHOD OF ROY-CAMILLE. ALL NEEDLE AND INSTRUMENT COUNTS WERE ACCURATE FOLLOWING THE PROCEDURE. THE PATIENT UNDERWENT ANTERIOR EXPOSURE OF L5-S1 PROCEDURE DUE TO DEGENERATIVE L5-S1. ON (B)(6) 2013, PATIENT PRESENTED FOR AN AMBULATORY ASSESSMENT. ASSESSMENT: LUMB/LUMBOSAC DISC DESIGN, LUMBOSACRAL SPONDYLOSIS, ANEMIA, HYPOMAGNESAEMIA, HYPOPHOSPHATEMIA. REPORTEDLY, THE PATIENT CONTINUES TO EXPERIENCE PAIN THAT RADIATES INTO HIS LOWER EXTREMITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64791 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M111301AAF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other