BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3830530 · Received May 23, 2014

    Report

    Report Number
    1030489-2014-02616
    Event Type
    Injury
    Date Received
    May 23, 2014
    Report Date
    May 1, 2014
    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)(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) 2005: THE PATIENT PRESENTED WITH CHRONIC NECK PAIN, SHOULDER PAIN AND PAIN INVOLVING THE ENTIRE SPINE, BOTH HIPS AND KNEES. PATIENT ALSO REPORTED THAT FROM PAST TWO MONTHS SHE HAD DEVELOPED CONTINUED OCCIPITAL HEADACHES. PATIENT'S EXAMINATION REVEALED DECREASED RANGE OF MOTION IN THE CERVICAL AND LUMBAR SPINE. PATIENT HAD LOCALIZED TENDERNESS THROUGHOUT THE ENTIRE SPINE, UPPER SHOULDERS AND OCCIPITAL REGION. PATIENT HAD PERSISTENT PARASPINAL MUSCLE SPASMS IN THE CERVICAL REGION. ASSESSMENT: PATIENT HAD A SEVERE CHRONIC PAIN SYNDROME DUE TO MULTIPLE FACTORS INCLUDING RHEUMATOID ARTHRITIS, DEGENERATIVE DISEASE OF THE ENTIRE SPINE, FIBROMYALGIA AND DEPRESSION. (B)(6) 2005: THE PATIENT UNDERWENT FOR MRI OF THE LUMBOSACRAL SPINE WITHOUT CONTRAST DUE TO LOW BACK PAIN. IMPRESSIONS: MILD CENTRAL SPINAL STENOSIS AT L1-2, SEVERE CENTRAL SPINAL STENOSIS AT L4-5, AND MODERATE SEVERE CENTRAL SPINAL STENOSIS AT L5-S1 AND AT L3-4. DISCOGENIC EDEMA IN ADJACENT BONE MARROW AT L1-2 AND L5-S1 PREDOMINANTLY. THERE IS ALSO SOME OF THE SAME AT L4-5; DISK PROTRUSION AT L3-4, L4-5 AND L5-S1 ACCOUNT FOR SOME PORTION OF THE CENTRAL SPINAL STENOSIS. NO ACUTE PROCESS IDENTIFIED. (B)(6) 2005: THE PATIENT UNDERWENT FOR MRI OF THE CERVICAL SPINE WITHOUT CONTRAST DUE TO NECK PAIN. IMPRESSION: MULTILEVEL DISCOGENIC DISEASE AND SPONDYLOSIS IN THE CERVICAL SPINE, WHICH CAUSES CENTRAL AND FORAMINAL STENOSIS AS DELINEATED. (B)(6) 2005: THE PATIENT PRESENTED FOR NEUROSURGERY CONSULTATION. DIAGNOSES: SPINAL STENOSIS; CERVICAL, DEGENERATIVE DISC DISEASE, C ERVICAL SPINE, NECK PAIN. (B)(6) 2006: THE PATIENT PRESENTED WITH FOLLOWING PRE-OPERATIVE DIAGNOSES: 1. MULTI-LEVEL CERVICAL SPINAL STENOSIS 2. ADVANCED DEGENERATIVE DISK DISEASE. 3. SUBLUXATION C3-4. 4. SPINAL CORD COMPRESSION AT MULTIPLE LEVELS. 5. MYELOPATHY. FOR WHICH THE PATIENT UNDERWENT FOLLOWING PROCEDURES: 1. C3, C4, C5, C6 AND UPPER C7 LAMINECTOMIES WITH BILATERAL FORAMINOTOMIES AT THE SAME LEVELS 2. POSTEROLATERAL FUSION WITH AUTOLOGOUS BONE GRAFT AND VERTEX INSTRUMENTATION. PER OP NOTES, 14MM AND 16-MM SCREWS WERE USED, BASED ON THE LENGTHS THAT SEEMED APPROPRIATE. THESE WERE PLACED AT C3, C4, C5, C6 AND C7. RODS WERE BENT TO THE PROPER SHAPE AND AFFIXED TO THE SCREWS, FIRST ON THE RIGHT-HAND SIDE AND THEN ON THE LEFT-HAND SIDE. NO COMPLICATIONS WERE NOTED. (B)(6) 2006: THE PATIENT PRESENTED WITH PRE-OP DIAGNOSES OF POSSIBLE WOUND INFECTION WITH NON-HEALING SECTION OF POSTERIOR CERVICAL WOUND. THE PATIENT UNDERWENT FOR FOLLOWING PROCEDURES: EXPLORATION OF WOUND REMOVAL OF RIGHT SIDED CERVICAL INSTRUMENTATION AND PRIMARY WOUND CLOSURE. PER OP NOTES, THERE APPEARED TO BE SOME GRANULATION TISSUE EXTENDING DOWN ON THE RIGHT HAND SIDE. X-RAY WAS TAKEN TO SEE IF THE INSTRUMENTATION WAS NEARBY, BECAUSE IT DID NOT APPEAR TO BE INFECTED. WHEN SURGEON CAME DOWN ON INSTRUMENTATION, WHAT BECAME APPARENT THAT THE LOWEST SCREW WAS LOOSE; HOWEVER, OTHER SCREWS DID NOT APPEAR TO BE LOOSE. THE GRANULATION TISSUE APPEARED TO BE COMING FROM BENEATH THE SCREW, POSSIBLY ASSOCIATED WITH MOVEMENT OF THE SCREW IN THE BONE; ALTHOUGH AN INFECTION CERTAINLY WAS POSSIBLE. SURGEON WENT AHEAD AND WENT ALL THE WAY UP TO THE TOP AND REMOVED A TOTAL OF 5 SCREWS AND 1 ROD. POST-OP DIAGNOSES WERE: POSSIBLE WOUND INFECTION WITH NON-HEALING SECTION OF POSTERIOR CERVICAL WOUND WITH A RIGHT SCREW FROM THE INSTRUMENTATION WITH SOME LOCAL GRANULATION TISSUE BUT NO CLEAR INFECTION. THERE WERE NO COMPLICATIONS. (B)(6) 2006: THE PATIENT WAS ADMITTED WITH A NON-HEALING LAMINECTOMY INCISION. SHE WAS TREATED WITH IV ANTIBIOTICS, UNDERWENT AN EXCISION OF SPINOUS PROCESS AND DEBRIDEMENT ON (B)(6). POST-OP, THE PATIENT MADE STABLE AND STEADY RECOVERY. THE PATIENT ALSO UNDERWENT FOR CHEST EXAM PA AND LATERAL PRE-OP WITH HISTORY OF HEAVY SMOKING FOR 43 YEARS. IMPRESSION: NO ACTIVE CARDIOPULMONARY DISEASE. (B)(6) 2006: THE PATIENT PRESENTED FOR CONSULTATION REGARDING NECK WOUND. REVIEW OF SYSTEMS SHOWED PATIENT HAD MILD POSTERIOR NECK DISCOMFORT. IMPRESSIONS: 1. STATUS POST C3-C7 FUSION WITH INSTRUMENTATION IN (B)(6) 2006; 2. STATUS POST REMOVAL OF PART OF THE HARDWARE ON (B)(6) 2006; 3. CHRONIC NON-HEALING NECK WOUND, RULE OUT FOREIGN BODY INFECTION, RULE OUT UNDERLYING OSTEOMYELITIS; 4. RHEUMATOID ARTHRITIS; 5. IMMUNOSUPPRESSION SECONDARY TO METHOTREXATE THERAPY; 6. HYPERTENSION; 7. STATUS POST ABDOMINAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY; 8. PENICILLIN ALLERGY; 9. CHRONIC OBSTRUCTIVE PULMONARY DISEASE. THE PATIENT WAS ALSO PRESENTED TO ANOTHER PHYSICIAN FOR CONSULTATION REGARDING MULTIPLE MEDICAL PROBLEMS. ASSESSMENT: 1. CHRONIC INFECTED C FUSION AND INCISION; 2. HYPERTENSION, CONTROLLED; 3. RHEUMATOID ARTHRITIS; 4. IMMUNOCOMPROMISED, ON METHOTREXATE; 5. OSTEOPOROSIS; 6. COPD, TOBACCO ABUSE; 7. SEASONAL ALLERGIES; 8. CHRONIC CONSTIPATION AND PRIOR ADHESIONS; 9. ANEMIA, PROBABLY SECONDARY TO CHRONIC DISEASE. ON THE SAME DAY, THE PATIENT ALSO UNDERWENT FOR MRI OF THE CERVICAL SPINE WITH AND WITHOUT CONTRAST DUE TO INFECTED LAMINOTOMY. IMPRESSION: OPERATIVE CHANGES POSTERIORLY IN CERVICAL AND UPPER THORACIC REGIONS FOLLOWING LAMINOTOMY FROM APPROXIMATELY C3-C6; ENHANCING SCAR TISSUE WAS PRESENT POSTERIORLY, BUT NO ABNORMAL FLUID COLLECTIONS WERE IDENTIFIED; EXTENSIVE CHRONIC DEGENERATIVE CHANGES OF CERVICAL SPINE. ALSO THE PATIENT UNDERWENT FOR MRI OF THE THORACIC SPINE WITH AND WITHOUT CONTRAST DUE TO INFECTED LAMINOTOMY. IMPRESSION: 1. EXTENSIVE CHRONIC DEGENERATIVE CHANGES OF THORACIC SPINE 2. OPERATIVE CHANGES POSTERIORLY IN CERVICAL AND UPPER THORACIC REGIONS BUT NO EVIDENCE OF ABNORMAL FLUID COLLECTION PRESENT. (B)(6) 2006: THE PATIENT PRESENTED FOR NUTRITION SCREEN AFTER BEING IDENTIFIED WITH NON-HEALING NECK WOUND AND WAS ADMITTED WITH INFECTED CERVICAL LAMINECTOMY. (B)(6) 2006: THE PATIENT UNDERWENT X-RAYS OF THE CHEST DUE TO PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) PLACEMENT. IMPRESSION: NO ACUTE CARDIOPULMONARY ABNORMALITY; TIP OF LEFT PICC LINE IN DISTAL INNOMINATE VEIN. (B)(6) 2006: THE PATIENT WAS FOUND STABLE FOR DISCHARGE ON IV ANTIBIOTICS AND WOUND VAC WITH CLOSE FOLLOW-UP ARRANGEMENTS. ON AN UNKNOWN IN 2007, THE PATIENT REPORTED DEEP SHOOTING PAIN AND ADMITTED TO HOSPITAL. THE PATIENT HAD MASSES ALL OVER IN THE RIGHT SIDE OF HER BODY AND THE DOCTOR REPORTEDLY SAID THAT IT LOOKS LIKE CANCER. (B)(6) 2007: THE PATIENT WAS ADMITTED WITH COMPLAINTS OF GENERALIZED FATIGUE AND ALSO WITH THE FOLLOWING DIAGNOSES: 1. ACUTE ANEMIA, UNKNOWN ETIOLOGY. 2. PAST MEDICAL HISTORY OF RHEUMATOID ARTHRITIS WITH NEW ELEVATION OF SED RATE. 3. CHRONIC OBSTRUCTIVE PULMONARY DISEASE, STABLE. 4. CHRONIC PAIN WHICH IS LONG TERM. 5. MILD DYSPEPSIA. (B)(6) 2007: THE PATIENT WAS DISCHARGED WITH THE FOLLOWING DIAGNOSES: 1. ACUTE ANEMIA, MOST LIKELY SECONDARY TO CHRONIC DISEASE WHILE CONTINUING TO RULE OUT EFFECT OF METHOTREXATE. 2. RHEUMATOID ARTHRITIS. AGAIN, SED RATE WAS ELEVATED ON ADMISSION. 3. HIATAL HERNIA NOTED ON EGD. 4. MILD REFLUX ESOPHAGITIS. 5. GASTRITIS. 6. DIVERTICULOSIS. 7. CHRONIC OBSTRUCTIVE PULMONARY DISEASE, STABLE. 8. CHRONIC PAIN. 9. GALLBLADDER MASS. (B)(6) 2008: THE PATIENT UNDERWENT FOR MRI OF ABDOMEN WITH AND WITHOUT CONTRAST AND COMPARISON WAS MADE WITH PRIOR CT DATED (B)(6) 2008. IMPRESSION: GALLBLADDER WALL THICKENING WITH ABNORMAL SIGNAL ENHANCEMENT IN THE ADJACENT LIVER SUSPICIOUS FOR GALLBLADDER CARCINOMA WITH INVASION. ATYPICAL INFECTIOUS OR INFLAMMATORY DISEASE CANNOT BE EXCLUDED. MILD INTRA AND EXTRA HEPATIC BILIARY DILATATION WITH NO OBSTRUCTING LESION DEMONSTRATED. BORDERLINE LEFT PERIAORTIC LYMPHADENOPATHY. LEFT RENAL CORTICAL SCARRING WITH POSSIBLE SUBACUTE TO CHRONIC INFARCTS. (B)(6) 2008: THE PATIENT UNDERWENT RIGHT UPPER QUADRANT ULTRA SOUND STUDY OF ABDOMEN DUE TO INDICATION FOR GALLBLADDER CANCER. (B)(6) 2008: THE PATIENT UNDERWENT FOR RIGHT UPPER QUADRANT ULTRASOUND DUE TO ABDOMINAL PAIN. IMPRESSION: 1. NO VISUALIZATION OF PREVIOUSLY NOTED VASCULAR MASS WITHIN THE GALLBLADDER LUMEN WHEN COMPARED TO THE (B)(6) 2008; 2. PERSISTENT INTRA- AND EXTRAHEPATIC BILIARY DILATATION WITH OVERALL DECREASE IN DILATATION OF THE COMMON BILE DUCT WHEN COMPARED TO PRIOR EXAMINATION; 3. INTERVAL DEVELOPMENT OF HYPOECHOIC LESION WITHIN THE HEAD OF THE PANCREAS ADJACENT TO THE COMMON BILE DUCT. DIFFERENTIAL DIAGNOSIS WOULD INCLUDE SMALL PANCREATIC PSEUDOCYST VERSUS PANCREATIC CYSTIC NEOPLASM. FURTHER EVALUATION WITH MRCP MAY BE OF BENEFIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT FUSION AT C3-4, C4-5, C5-6, AND C6-7 USING RHBMP-2/ACS. IT WAS REPORTED THAT POST-OPERATIVELY THE PATIENT DEVELOPED AUTONOMIC NEUROPATHY, SMALL FIBER NEUROPATHY, PERIPHERAL NEUROPATHY, MUSCLE ATROPHY AND NERVE DAMAGE, EXTREME INFLAMMATORY REACTIONS, CHRONIC RADICULITIS, STERILITY, OSTEOLYSIS (BONE RESORPTION), DISPLACEMENT OR MIGRATION OF THE SPACER CAGE, PSEUDOARTHROSIS, DIFFICULTY SWALLOWING, DIFFICULTY BREATHING, AND DIFFICULTY GRIPPING AND HOLDING ITEMS, CHRONIC PAIN AND WORSE OVERALL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308668 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 Required Intervention