MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Abscess (1690); Anxiety (2328)

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

It was reported per patient's medical records that on: an unknown date, the patient underwent fusion surgery, in which rhbmp-2 was implanted.On (b)(6) 2006: the patient presented for a scoliosis check.She seemed to have significant thoracic scoliosis on examination with asymmetry of her posterior thorax on the right, enlargement.On (b)(6) 2006: the patient presented with a dextroconvex mild thoracic scoliosis measuring 32 degrees.A compensatory levoconvex lumbar scoliosis was also present measuring 21 degrees.On (b)(6) 2006: the patient presented with persistent headaches and also complained of occasional mild epistaxis.She also had scoliosis.On (b)(6) 2007: the patient complained of bilateral ear pain, congestion and cough.On (b)(6) 2008: the patient presented for a pre-op physical.She was about to having a scoliosis surgery.She had close to a 45 degree that had progressed.She was starting to have pain and discomfort and therefore a percutaneous procedure was planned for her scoliosis.On (b)(6) 2008: the patient underwent a spinal scoliosis fusion.On (b)(6) 2009: the patient presented status post minimalization of scoliosis surgery.She was also depressed and had anxiety.A lot of her symptoms sounded like a young adult attention deficit hyperactivity disorder.On (b)(6) 2009: the patient presented with headaches, fatigue, back pain, chills, nausea, constipation, muscle pain, myalgia and stiffness.On (b)(6) 2010: the patient presented with an injury on right foot.She also complained of headaches and constipation.On (b)(6) 2010: the patient presented with mood swings, insomnia and fatigue.On (b)(6) 2010 the patient presented and had slurred speech, dilated eyes, body aches and eye pain.On (b)(6) 2010: the patient underwent ct scan of head due to headache.Impression: right posterior ethmoid sinus disease.On (b)(6) 2010: the patient presented with trouble in school due to mood swings.On (b)(6) 2010: the patient presented for an office visit with an adverse reaction to biaxin.She had upper respiratory infection recently.On (b)(6) 2010: the patient presented for follow-up on her abdominal pain, nausea, vomiting and dehydration.On (b)(6) 2010: the patient presented complaining of fatigue.She also complained of depression.Assessments: fatigue, epistaxis, panic attack, depression.On (b)(6) 2010: the patient presented with anxiety and complained of panic attacks.Assessments: attention deficit hyperactivity disorder, anxiety, gastroesophageal reflux disease, mood disorder.On (b)(6) 2011: the patient presented with depression.Assessments: attention deficit hyperactivity disorder, anxiety, mood disorder, warts, intractable migraine.On (b)(6) 2011: the patient presented with sinusitis bronchitis and anxiety and depression.Assessments: attention deficit hyperactivity disorder, anxiety, asthmatic bronchitis.On (b)(6) 2012: the patient presented with a long history of anxiety and depression due to the death of her father.On (b)(6) 2012: the patient presented with follow-up on her anxiety, depression and attention deficit hyperactivity disorder.On (b)(6) 2012: the patient presented with a follow-up on her pyelonephritis.Assessments: urinary tract infection, pyelonephritis, attention deficit hyperactivity disorder, mood disorder.On (b)(6) 2012: the patient presented with nausea and dehydration.She also complained of migraines and abdominal pain nausea following meals.She also had increased anxiety panic attacks.On (b)(6) 2013: the patient presented with increased frequency of migraine headaches, nausea, blurred vision.Headaches pressure occipital region through the frontal part of her head blood pressure and pain.On (b)(6) 2013: the patient presented with anxiety and seizure episodes.Assessment: mood disorder; attention deficit hyperactivity disorder.On (b)(6) 2013: the patient presented with migraine.On (b)(6) 2014: the patient presented with low abdominal pain.She also complained of right flank pain.She underwent ct of abdomen and pelvis.Impression: 1.5mm right "uvj" calculus results in moderate hydronephrosis and hydroureter.She was discharged in good condition.On (b)(6) 2014: the patient presented with the following pre-op diagnosis: history of right flank pain with questionable right distal ureteral calculus.She underwent the following procedure: cystoscopy and right retrograde pyelogram.No patient complications were reported.She was discharged.On (b)(6) 2014: the patient presented with pain and vomiting conditions.On (b)(6) 2014: the patient presented with fever and coughing up blood in sputum.She was diagnosed with upper respiratory infection - bronchitis.On (b)(6) 2014: the patient presented with insect bite.On (b)(6) 2014: the patient presented with headache and chest pain.She also complained of mid back pain and discomfort over the midthoracic spine, migraine headaches.On (b)(6) 2014: the patient presented with migraine, sinus problem, cough and ear fullness.She also complained of anxiety, depression, diffuse pain everywhere especially across the upper back and shoulders.On (b)(6) 2014: the patient presented with chronic neck and back pain.She underwent x-rays of the cervical and thoracic spine.Impression: straightened cervical spine with a mild dextroscoliosis; dextroscoliosis of the lower thoracic spine treated with a fixation rod/pedicle screws; no evidence of screw loosening or hardware infection.On (b)(6) 2014: the patient presented with chronic back pain and headache.She could not tolerate cymbalta and therefore it was discontinued.She also complained of not able to sleep.On (b)(6) 2015: the patient presented and complained of sore on the right inner thigh.She was diagnosed with early abscess/cellulitis.On (b)(6) 2015: the patient presented with significantly worse thoracic back pain.She reported that since previous 3-4 months, she started to have pain to her anterior chest and towards her right axilla area.Her x-rays demonstrated previous posterior instrumentation from t4 to t12.Impression: pain following scoliosis surgery.Questionable pseudoarthrosis.On (b)(6) 2015: the patient presented after her right leg abscess drained.On (b)(6) 2015: the patient underwent ct scan of her thoracic spine due to pain.Impression: no evidence of screw loosening or hardware infection.Minor disk interspace narrowing, likely the result of the scoliosis.Thoracic facet joint arthropathy and degenerative change along with fusion at some of the fixed levels.No evidence of bone or soft tissue infection.On (b)(6) 2015: the patient presented for a follow-up visit.She underwent a ct scan, which showed a posterior fusion mass that apeared relatively solid from the t4 to t12 area.She had a left t7 screw which was slightly medial in the canal but seemed to be okay otherwise.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6700032
• MDR Text Key: 79577773
• Report Number: 1030489-2017-01716
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/12/2017
• Initial Date FDA Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 63