BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3140625 · Received May 31, 2013

    Report

    Report Number
    1030489-2013-02041
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 3, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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

    ON (B)(6) 2005 SPINAL FUSION: PRE-OP DIAGNOSTIC: SPINAL DEFORMITY AND FAILED T10 TO S1 FUSION. ON (B)(6) 2005: POSTEROLATERAL FUSION FROM T10 TO S1 WITH USE OF PRIOR SEGMENTAL LEVELS AND ADDITION WITH INFUSE/BMP AND MASTERGRAFT, REMOVAL OF PREVIOUS HARDWARE, AND EXPLORATION OF PREVIOUS FUSION. BMP PLACED INTO POSTEROLATERAL GUTTERS AT T10, T11, T12, L1, L2, L3, L4, L5, AND S1. GOOD HEMOSTASIS WAS MAINTAINED. NOTED: NO BONY FUSION MASS WAS DISCOVERED DURING SURGERY. HETEROTOPIC BONE FORMATION RESULTING FROM USE OF BMP AT L4-5 AND L5-S1, SEVERE SPINAL CORD NARROWING AT L4-5 (ABNORMAL BONE GROWTH NOTED DURING (B)(6) 2008 REVISION SURGERY). SEVERE LEFT NEURAL FORAMINA NARROWING AT L4-L5-S1. ON (B)(6) 2005: PEDICLE SCREW DISCONNECTED OR FRACTURED AT CONNECTION WITH ROD (B)(6) 2007: EVIDENCE OF HARDWARE LOOSENING TRANSPEDICULAR SCREWS AT L3, L5, AND S1 (B)(6) 2008: REMOVAL OLD HARDWARE, EXCISION L4-6,S1, PLIF WITH BMP AND MASTERGRAFT, ALIF AT L5-6, ALIF L6-S1 USING BMP AND MASTERGRAFT INSIDE DEPUY CAGES. NOTED: IRREGULAR BONY EROSION AND TREMENDOUS AMOUNT OF SCAR TISSUE AT L5-6, NEW CAGE WITH BMP COULD NOT BE COMPLETELY IMPACTED INTO DISC SPACE BECAUSE OF SCAR TISSUE. PATIENT UNDERWENT CERVICAL FUSION (B)(6) 2008, SUBSEQUENTLY WENT TO INPATIENT REHAB AND WAS DISCHARGED (B)(6) 2008. REFERRED TO OP PT FOR CONTINUED STRENGTH/BALANCE AND GAIT TRAINING. PATIENT UNDERWENT INTENSE PHYSICAL AND OCCUPATIONAL THERAPY COURSES TO GAIN STRENGTH, AMBULATE WITHOUT WALKER, AND IMPROVE BALANCE. ON (B)(6) 2008: EVIDENCE OF IMPLANT LOOSENING S1 AND L6, NONUNION AT L4-5 ,CHRONIC INTRACTABLE BACK PAIN, BILATERAL LEG PAIN, MORE RIGHT THAN LEFT (B)(6) 2008: PREOPERATIVE DIAGNOSIS: HETEROTOPIC BONE FORMATION RELATED TO BMP USE IN THE LUMBOSACRAL SPINE RESULTING IN BOTH CENTRAL AND LATERAL SPINAL STENOSIS AT L4-5 AND L5-S1, NONUNION OF L4-S1 INSTRUMENTED FUSION, DEGENERATIVE SCOLIOSIS WITH SIGNIFICANT FUNCTIONAL DISABILITY. SURGERY NOTES: BONY MASS SECONDARY TO USE OF BMP SO LARGE THAT THE PATIENT CLAIMS HE COULD FEEL PRESSURE WHILE SITTING. PSEUDOARTHROSIS IN POSTEROLATERAL GUTTERS WITH LOOSENING OF HARDWARE. DIFFICULT REMOVAL OF EXUBERANT/ECTOPIC BONE GROWTH, BMP ROLLED AND FILLED WITH AUTO BONE CHIPS, PLACED IN POSTEROLATERAL GUTTERS BILATERALLY AT L4-S1. ON (B)(6) 2008: CT CERVICAL SPINE: REVERSAL OF CERVICAL CURVATURE. MINIMAL ANTEROLISTHESIS IS NOTED AT C7-T1 LEVEL. POSTOP CHANGES NOTED WITH C4, C5, C6 LAMINECTOMIES. POSTERIOR SURGICAL FIXATION WITH PEDICULAR SCREWS AND RODS ARE NOTED. MODERATE CANAL STENOSIS AT C6-C7 LEVEL. MULTI LEVEL NEURAL FORAMEN STENOSIS NOTED AT C3-C4. CERVICAL MYELOPATHY WITH INSTABILITY. ON (B)(6) 2009: PATIENT HAD SET BACK, FELL OUT OF BED, NOTES NO INJURIES BUT STILL HAS ARM PAIN AND UNABLE TO HOLD ARM UP LONG PERIOD OF TIME. WAKES UP AT NIGHT WHEN ARM IS NOT SUPPORTED AND HAS PAIN. ON (B)(6) 2011: CT SCAN LUMBAR SPINE. SURGICAL CHANGES STATUS POST INTERBODY AND/OR DORSAL SPINAL FUSION AT EACH LEVEL FROM T11 TO THE SACRUM WITH MODERATE LUMBAR SCOLIOSIS APEX TO THE LEFT, STRAIGHTENING OF THE LUMBAR LORDOSIS, POSTERIOR HARDWARE REMOVAL AT EACH LEVEL. SOLID INTERBODY/POSTERIOR SPINAL FUSIONS AT EACH LEVEL FROM T12 TO SACRUM WITH MILD RESIDUAL NARROWING OF THE NEURAL FORAMINA AT MULTIPLE LEVELS. SOLID POSTERIOR SPINAL FUSIONS T11-12 WITH PERSISTENT INTERBODY MOTION AS INDICATED BY GAS WITHIN THE DISC. MODERATE BILATERAL SACROILIAC OSTEOARTHRITIS. EVIDENCE OF BILATERAL HIP OSTEOARTHRITIS. ON (B)(6) 2011: SPINE EXAM: OBVIOUS SCOLIOSIS WITH WELL HEALED SURGICAL SCARS. RANGE OF MOTION OF SPINE IS SIGNIFICANTLY DECREASED IN FLEXION, AGAINST WALL PATIENT STILL AT 45 DEGREE ANGLE HUNCHED FORWARD. PATIENT ABLE TO FLEX WITHOUT INCREASED PAIN. NO TENDERNESS TO PALPATION IN THE PARASPINAL MUSCLES AND PAIN IS WORSE WITH EXTENSION. RIGHT AND LEFT LEG RAISES INCREASE BACK PAIN. MULTIPLE FOLLOW UP OFFICE VISITS WITH LAST ONE DOCUMENTED ON (B)(6) 2012. REPORTS THAT LBP IS UNDER CONTROL, PHYSICAL THERAPY IS ONGOING WITH POSITIVE PROGRESS. PATIENT FEELS SPINE IS STRONGER AND ABLE TO STAND STRAIGHTER. PATIENT WILL CONTINUE FENTANYL 37 MCG AND PERCOCET UP TO 4 TABS A DAY AND WILL CONTINUE PHYSICAL THERAPY. WILL RE-EVALUATE IN 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241199 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110701AAD

    Patients

    Seq Age Sex Outcome Treatment
    1