BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 5093488 · Received September 22, 2015

    Report

    Report Number
    1030489-2015-02457
    Event Type
    Injury
    Date Received
    September 22, 2015
    Report Date
    August 24, 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)(6). (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2011: THE PATIENT UNDERWENT SURGERY. PREOP: DISKOGENIC PAIN L4-5 WITH RETAINED HARDWARE L3-4. PROCEDURE: 1) REVISION LAMINECTOMY L4-L5, BILATERAL, WITH DECOMPRESSION OF L4 AND L5 NERVE ROOTS. 2) POSTEROLATERAL FUSION L3-L4. 3) REMOVAL OF STEFFEE PLATES L3-L4. 4) SPINECRAFT APEX TITANIUM PEDICLE SCREW SYSTEM L3, L4, AND L5. 5) L4-L5 POSTERIOR LUMBAR INTERBODY FUSION. 6) SPINECRAFT 12 MM X 26 MM INTERBODY EDGES L4-L5 DISK SPACE. 7) LOCAL BONE GRAFT WITH RHBMP-2/ACS ALLOGRAFT AND DEPUY EQUIVABONE CALCIUM PRODUCT. PEROP: USINQ THA SPINECRAFT APEX TITANIUM PEDICLE SCREW SYSTEM, SCREWS WERE PLACED AT L3, L4, AND L5. ALL SCREWS WERE THEN TESTED AND NOTED TO BE WITHIN TRIGGER EMG LIMITS. CONTOURED RODS WERE THEN TRIMMED DOWN. PLIF WAS THEN PERFORMED TO THE PATIENT'S LEFT SIDE AT L4-L5 USING STANDARD ANNULECTOMY APPROACH, EVACUATING THE DISK SPACE, PUTTING IN RHBMP-2/ACS ONE HALF SPONGE FOLLOWED BY LAMINECTOMY BONE, FOLLOWED BY INTERBODY CAGES, FOLLOWED BY ADDITIONAL BONE GRAFT PACKED BETWEEN THE TWO CAGES. (B)(6) 2011: THE PATIENT PRESENTED WITH LOW BACK DISCOMFORT. PER THE X-RAY RECORDS AP AND LATERAL VIEWS OF THE LUMBAR SPINE, REVEAL EXCELLENT POSITION OF HARDWARE AT 13-L4-L5. CAGE WAS IN EXCELLENT POSITION AT L4-L5. IMPRESSION: POSTLARNINECTOMY SYNDROME. (B)(6) 2011: THE PATIENT PRESENTED WITH LOW BACK DISCOMFORT. PER THE X-RAY RECORDS. AP AND LATERAL VIEWS OF THE LUMBAR SPINE REVEAL L3-L4-L5 INSTRUMENTATION WITHOUT EVIDENCE OF LOOSENING, L4-L5 INCREASED CONSOLIDATION OF THE INTERBODY FUSION. (B)(6) 2012: THE PATIENT PRESENTED WITH LOWER BACK STIFFNESS. PER THE X-RAY RECORDS SOLID FUSION OCCURRING AT L4-5. (B)(6) 2012: THE PATIENT PRESENTED WITH LEFT KNEE PAIN. IMPRESSION: CHONDROMALACIA OF BOTH KNEES BOTH SYMPTOMATIC. (B)(6) 2012: THE PATIENT PRESENTED WITH KNEE PAIN. IMPRESSION: POSTLAMINECTOMY SYNDROME, CHONDROMALACIA OF BOTH KNEES. (B)(6) 2012: THE PATIENT PRESENTED WITH LOWER BACK PAIN AND BILATERAL KNEE PAIN. PER THE X-RAY RECORDS EXCELLENT SOLID FUSION OCCURRING AT L4-5 THE LEVEL BELOW THE PREVIOUS FUSION WITH PEDICULAR INSTRUMENTATION AT L3-L4-L5. (B)(6) 2012: THE PATIENT WENT FOR AN OFFICE VISIT. ASSESSMENT: SCIATICA. (B)(6) 2012: THE PATIENT PRESENTED WITH NECK PAIN, LOWER BACK PAIN, BILATERAL ARM PARESTHESIAS, LOWER EXTREMITY PARESTHESIAS, PAIN. IMPRESSION: CERVICAL RADICULOPATHY. ASSESSMENT: BRACHIAL NEURITIS OR RADICULITIS, BODY MASS INDEX. (B)(6) 2012: THE PATIENT PRESENTED WITH NECK PAIN, LOWER BACK PAIN, BILATERAL ARM PARESTHESIAS, LOWER EXTREMITY PARESTHESIAS, PAIN. PER THE MEDICAL RECORDS. SOLID FUSION AT L3-L4-L5. THERE WAS NO EVIDENCE OF ANY PSEUDARTHROSIS. ASSESSMENT: LUMBAGO, BODY MASS INDEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626251 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 Other