BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 5301366 · Received December 16, 2015

    Report

    Report Number
    1030489-2015-03454
    Event Type
    Injury
    Date Received
    December 16, 2015
    Report Date
    November 23, 2015
    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
    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) 2004 THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: 1. ANTERIOR THORACOTOMY, T8 APPROACH, 2. ANTERIOR DISKECTOMIES, T8-9, T9-T10, ANTERIOR OSTEOTOMIES T10-T1, AND T11 - T12, 4. NEUROMONITORING TO TREAT THE FOLLOWING PRE-OP DIAGNOSIS: PROGRESSIVE POSTTRAUMATIC THORACIC KYPHOSIS. ON (B)(6) 2004 THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: 1. POSTERIOR SPINAL FUSION, T2 TO L2, 2. SMITH-PETERSEN OSTEOTOMIES AT T4-5, T5-6, T6-7, T8-9, T11-12, 3. REPAIR OF DUROTOMY, 4. PEDICLE SCREW SEGMENTAL FIXATION, T2 TO L2. 5. LAMINOTOMY AT L1-2, 6. NEURAL MONITORING TO TREAT THE FOLLOWING PRE-OP DIAGNOSIS: PROGRESSIVE PROGRESSIVE POSTTRAUMATIC THORACIC KYPHOSIS. FINDINGS: PSEUDOARTHROSES. OP NOTES: THE PATIENT HAD PREVIOUS BILATERAL ILIAC CREST BONE GRAFTS AND THEREFORE PLANS WERE TO USE ALLOGRAFT AND BONE MORPHOGENIC PROTEIN. LOCALIZING X-RAYS WERE TAKEN OF THE LUMBAR AND THORACIC SPINE. THE SPINE WAS CONTINUOUSLY STRIPPED AND THE ENTIRE FUSION MASS FROM THE CENTRAL TO ITS LATERAL BORDERS WAS EXPOSED. PSEUDOARTHROSIS WAS NOTED AT MULTIPLE LEVELS, ESPECIALLY IN THE INFERIOR SEGMENTS. IT WAS NECESSARY TO PERFORM A LAMINECTOMY AT L2 TO SAFELY PLACE THE PEDICLE SCREWS AT THIS LEVEL IN THE ABSENCE OF ADEQUATE BONE LANDMARKS. PEDICLE FASHION USING ALSO PLACED AT T7. THESE WERE PERFORMED IN THE STANDARD FASHION USING ANATOMIC LANDMARKS USING M10 SYSTEM AND 4.5MM PEDICLE SCREWS IN THE THORACIC SPINE AND 5.5 MM PEDICLE SCREWS IN THE LUMBAR SPINE. WITH OSTEOTOMIES PREFORMED, A ROD WAS INSERTED. THE PREBENT ROD WAS FASHIONED IN ORDER TO DECREASE THE KYPHOSIS OF THE THORACIC SPINE AND APPROXIMATED ONTO THE PEDICLE SCREWS WITH SET SCREWS AND A PERSUADER DEVICE. AN X-RAY WAS TAKEN TO CONFIRM IMPROVEMENT OF THE PATIENT'S THORACIC KYPHOSIS WITH APPROXIMATELY 88 DEG. INITIALLY TO LESS THAN 65 DEG. WITH INSTRUMENTATION. IN DISTRACTING PEDICLE SCREWS CUT OUT, WITHOUT CHANGES IN NEURAL MONITORING. THIS SCREW WAS REMOVED AND THE DECISION WAS MADE TO GO WITH A SUBLAMINAR WIRE AT THAT LEVEL. WITH X-RAYS CONFIRMING APPROPRIATE ANTERIOR, POSTERIOR AND LATERAL POSITIONING OF THE IMPLANTS AND CORRECTION OF KYPHOSIS, A ROD WAS FASHIONED FOR THE RIGHT SIDE AND ATTACHED TO THE M10 PEDICLE SCREWS. DECORTICATION WAS THEN UNDERTAKEN, FOLLOWING BY PLACEMENT OF ALL REMNANT AUTOLOGOUS BONE GRAFT FROM THE SPINOUS PROCESSES REMOVED FROM THE BACK AND BONE MORPHOGENIC PROTEIN WAS PLACED AT THE DISTAL-MOST ASPECT OF THE FUSION MASS. DECORTICATION WAS UNDERTAKEN AND FINAL TIGHTENING OF ALL SCREWS AND HARDWARE WAS PERFORMED. THE PATIENT WAS NOT EXTUBATED BUT WAS RATHER TAKEN TO THE INTENSIVE CARE UNIT FOR OVERNIGHT POSTOPERATIVE MANAGEMENT. ON AN UNKNOWN DATE POST-OP PATIENT ALLEGED UNSPECIFIED INJURIES DUE TO USE OF RHBMP-2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831258 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