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

Catalog Number 7510600

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

Patient Problems Cyst(s) (1800); Dyspnea (1816); Fatigue (1849); Fever (1858); Headache (1880); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Tachycardia (2095); Thyroid Problems (2102); Tingling (2171); Cramp(s) (2193); Chronic Obstructive Pulmonary Disease (COPD) (2237); Stenosis (2263); Sinus Perforation (2277); Injury (2348); Inadequate Pain Relief (2388); Neck Pain (2433); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

It was reported that on (b)(6) 2010, patient again underwent spinal fusion surgery on the lumbar region where selected parts of rhbmp-2/acs (i.E.Only rhbmp-2 and collagen sponge) were used.The rhbmp-2 collagen sponge was applied via a posterior approach.The rhbmp-2 collagen sponge was placed outside the cage.Post-op, patient complained of worsening pain in the low back with pain and radiculopathy in the lower extremities.Patient continues to experience chronic low back pain in hips and her lower extremities.The patient had extreme left leg pain and difficulty in walking.These serious injuries prevent the patient from practicing and enjoying the activities of daily life that patient enjoyed pre-operatively, and had otherwise suffered serious and permanent injuries.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on, (b)(6) 2010: the patient was preoperatively diagnosed with loose hardware and failed fusion l4-l5 and underwent following procedures: removal of hardware l4-l5.Posterior fusion l4-l5 fixation including ha-coated screws, two large kits of bmp, 30 cc of crushed cancellous allograft.As per op-notes, "we removed the hardware l4 to s1.Once this hardware was removed, we stuffed the previous holes with surgical and began to localize the bone.We prepared two large kits of bmp per protocol.We began by placing half sponge of bmp with crushed cancellous allografts stuffed into the facet joint itself and then we placed bmp around in that area as well as additional crushed graft.We used approximately four sponges per side slightly more and three sponges were not used.We placed crushed allograft all around in that area through separate layers wrapping the bmp in almost like a burrito configuration.The hardware was then placed.We used ha-coated screws and the peek rod system.We used a 45 mm rod bilaterally." no patient complications were reported.On (b)(6) 2010: the patient presented for removal of sutures.On (b)(6) 2010, (b)(6) 2011: the patient presented for follow up visit due to back pain status post surgery.On (b)(6) 2011, (b)(6) 2012, (b)(6) 2013: the patient presented for follow up for low back pain and neck pain.Assessment: spondylosis; cervical without myelopathy, brachial neuritis or radiculitis.On (b)(6) 2011: the patient presented for follow up for thoracic pain, neck and headaches.Patient stated pain is dull in neck and has tingling in left arm.On (b)(6) 2012, (b)(6) 2013: the patient presented for follow up for neck pain, aching pain in neck and pulling sensation due to cold weather.On (b)(6) 2012: the patient underwent mri of thoracic spine without contrast.Impressions: mild degenerative changes at the thoracolumbar junction.On (b)(6) 2013: the patient presented with a chief complaint of fatigue and thyroid mass.On (b)(6) 2013: the patient underwent x-ray of lumbosacral spine, 2 views due to low back pain, and postoperative changes in lumbosacral spine.Impression: postoperative changes at l4-l5 and l5-s1 intact.No fracture subluxation or bone destructive process.The patient also underwent ultrasound of pelvis due to pelvic pain.Impression: essentially normal.Ultrasound of the pelvis.The patient underwent bilateral screening mammography.Impression: bi-rads category 2: benign findings.The patient also underwent ultrasound of the soft tissues of the posterior upper right leg.Impression: no ultrasound findings in the area of interest in the posterior right upper leg.(b)(6) 2013: the patient presented for office visit due to neck pain and medication follow up.On (b)(6) 2013: the patient presented for test results.Assessment: pain in limb, lumbago, unspecified reduction deformity of lower limb, depressive disorder, unspecified hypothyroidism, cyst of thyroid, goiter, tachycardia, chronic pain syndrome, overweight, non independent abuse of drugs, tobacco use disorder.On (b)(6) 2013: the patient presented for refilling of medications.On (b)(6) 2013: the patient presented for abdominal pain, constipation and colonoscopy.The patient underwent thyroid sonogram.Impression: enlargement of the right thyroid lobe consistent with a goiter.A cystic nodule, right thyroid lobe, measuring up to 14 mm.On (b)(6) 2013: the patient underwent mri of cervical spine without contrast.Impression: the dominant finding is diffuse degenerative disease, most severe at c5-c6.Severe left and moderate right foraminal stenosis at c5-c6 with mild canal stenosis to an anterior posterior dimension of 8mm.There is also moderate left sided foraminal narrowing at c3-c4, c4-c5 and moderate bilateral foraminal stenosis at c6-c7.No evidence of cord signal abnormality at any level.On (b)(6) 2013: the patient presented with chief complaint of cough, "ha", fever, body aches and coughing up thick yellow mucus.(b)(6) 2014: the patient presented for neck pain, sharp pain in neck and radiating to shoulders.Patient stated that the pain interferes in activities.On (b)(6) 2014: the patient presented with chief complaint of shortness of breath with exercise, cough and sinus pressure.On (b)(6) 2014: the patient underwent chest x-ray 2 views due to shortness of breath.Impression: no active lung disease.On (b)(6) 2014: the patient underwent bilateral screening mammography.Impression: stable mammographic appearance with no new findings to suggest malignancy.On (b)(6) 2014: on a telephonic conversation, patient medications prescribed.On (b)(6) 2014: the patient presented with a complaint of constipation, cough and ear pain.On (b)(6) 2013, (b)(6) 2014: the patient presented for test results.Assessment: sinusitis, unilateral headache, cough, hypothyroidism, tachycardia, overweight.On (b)(6) 2014: the patient underwent ct scan of brain without contrast.Impression: no acute hemorrhage, edema or mass effect.On (b)(6) 2014: the patient presented with a complaint of shortness of breath.On (b)(6) 2014: the patient underwent ultrasound of the left upper extremity in the area just proximal to the antecubital fossa due to palpable mass.Impression: no focal cord or visible palpable abnormality.This may be prominent musculature or other soft tissue ab normality.The patient also underwent chest x-ray 2 views.Impression: mild osteoarthritis of the thoracic spine.The patient also underwent ultrasound of the left upper extremity medial proximal biceps region due to pain in area.Impression: focal hyperechoic area in the area of the clinical concern.The etiology is uncertain.On (b)(6) 2014: the patient presented for leg cramping, muscle or joint pain, stiffness and back pain.On (b)(6) 2014: the patient underwent pft pulmonary function test.Impression: chronic airways obstruction, moderate severity.The patient underwent mri of left arm with and without contrast.Impression: the palpable area is marked in the medial anterior arm.Only normal signal is there in this area.Normal subcutaneous fat and muscles and osseous structures and vessels.No abnormal enhancement or suspicious lesion.If there is continued progression of palpable event in this area, palpation guided biopsy can be considered.On (b)(6) 2014, (b)(6) 2015: the patient presented for chronic back pain.

Event Description

It was reported that on (b)(6) 2011: the patient underwent ct scan of lumbar status post op 3 lumbar surgeries.Impression: l4-l5 disc replacement with posterior fusion.No evidence of hardware loosening or displacement.Solid anterior fusion of l5-s1.L3-l4 posterior disc bulge.On (b)(6) 2011: the patient underwent ct lumbar spine status post decompression/fusion and l4-l5 disc replacement.Impression: stable appearing decompression/fusion/disc replacement changes at l4-l5 and l5-s1 with no fracture, subluxation or osseous destruction and no non-contrast ct evidence of central canal or foraminal stenosis.On (b)(6) 2011: the patient underwent ct of lumbar spine.Impression: posterior rod and screw fixation of l4 on l5 with associated l4-l5 intervertebral disc prosthesis.No evidence of hardware failure.Two interbody devices within the l5-s1 disc space with complete osseous fusion across the disc space without evidence of hardware failure.L3-l4 level: mild annular disc bulge without significant central canal stenosis or neuroforaminal exit stenosis.Facet arthropathy from l3-l4 and l5-s1.On (b)(6) 2012 patient underwent ct scan of the abdomen and pelvis without contrast.Impression: no kidney stone, ureter stone or hydronephrosis, no bowel obstruction normal appendix, arthritic changes and postsurgical changes, lower lumbar spine.On (b)(6) 2014: as per the medical record, assessment: chronic back pain decreased rom for back.On (b)(6) 2014, (b)(6) 2015, (b)(6) 2016 as per the medical records, assessment: chronic pain.On (b)(6) 2015 patient underwent three radiological views of right ankle.Impression: post-surgical changes of distal tibia and fibula without evidence of hardware abnormality, no convincing acute osseous abnormality.On (b)(6) 2015 patient underwent two radiological views of chest.Due to cough and white sputum.On an unknown date, the patient was diagnosed for spinal cord injury due to compression neuropathy secondary to traumatic degenerative disc disease of lumbar spine with radiculopathy.

Event Description

It was reported that on: (b)(6) 2013: the patient presented for test results.Assessment: unspecified thyroidism, depressive disorder, lumbago, left lower quadrant abdominal pain, unspecified constipation, unspecified, tobacco use disorder, tachycardia.On (b)(6) 2015: the patient presented for test results.Assessment/plan: ex-smoker, over-weight, hypothyroidism, moderate chronic obstructive pulmonary disease, sleep disorder, tachycardia, chronic pain syndrome (b)(6) 2015 patient underwent two radiological views of chest.Due to cough and white sputum.Impression: no acute findings.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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; medtronic sofamor danek usa, i; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5104118
• MDR Text Key: 26758647
• Report Number: 1030489-2015-02497
• 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: Followup,Followup,Followup,Followup
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2012
• Device Catalogue Number: 7510600
• Device Lot Number: M110812AAM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2010
• 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: 91