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

Catalog Number 7510800

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

Patient Problems Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Swelling (2091); Weakness (2145); Numbness (2415); Ambulation Difficulties (2544); Osteopenia/ Osteoporosis (2651); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that the patient presented with the postoperative diagnosis of post laminectomy and instrumented fusion l3-l5; adjacent level disease l2-3 and l5-s1; loose hardware l4, left, secondary to osteoporosis, and degenerative scoliosis l2-s1.The patient underwent surgery which consisted of a removal of segmental spinal instrumentation l3-l5, left; evaluation of fusion mass l3-l5; revision laminectomy l5 and s1, bilateral; neurolysis s1 nerve roots bilaterally; harvest autograft; preparation of allograft; posterolateral fusion l2-3 and l5-s1; revision fusion l3-l5; placement of ebi fusion stimulator; creation of subcutaneous pouch, left; interpretation and biplanar fluoroscopy; and microsurgical technique with fiberoptic coaxial headlight and surgical loops.Per the operative notes ¿¿the hardware along the right side was covered by a full fusion mass well incorporated along the left side.There was evidence of pseudoarthrosis (left l3-5) and the hardware was much more accessible.The hardware was removed along the left side with a loose l4 screw which had shifted due to osteoporosis¿¿ no patient complications were noted.(b)(6) 2011: the patient underwent a venous duplex of the bilateral lower extremities which revealed no evidence of thrombosis.(b)(6) 2011: the patient was discharged from hospital.(b)(6) 2011: the patient presented with improved leg pain.There was some slight drainage from the wound area.X-rays showed intact instrumentation.(b)(6) 2011: the patient presented with pain and underwent lumbar x-rays which demonstrated levorotoscoliosis.There was spondylolisthesis at the l4-5 level.There was diffuse osteopenia.(b)(6) 2011: the patient presented with improved leg and back pain.Medications: percocet and vicodin.(b)(6) 2011.The patient presented with back pain and underwent lumbar x-rays which showed ¿extensive bone graft material noted within the posterior elements at these levels.The disc spaces are narrowed at the l2-3, l3-4, l4-5 and l5-s1 levels.The facet joints are narrowed and hypertrophic l3 through s1.¿ (b)(6) 2011: the patient presented with an increase in leg pain primarily over the anterior thigh, knee and into the pre-tibial area.The patient also had complaints of right shoulder pain (right shoulder impingement).Medications: vicodin and tylenol.(b)(6) 2011: the patient presented with copd and lower back and leg pain.The patient also reported poor balance, difficulty walking, and shoulder and knee pain secondary to arthritis.(b)(6) 2011: the patient presented with lumbar radiculopathy.The patient descried the pain as sharp and radiating down the leg.(b)(6) 2011: the patient presented with pain and underwent lumbar spine x-rays which demonstrated narrowed facet joints and sclerotic at l3-4, l4-5, and l5-s1 and there was slight spondylolisthesis of l4-5, grade 1.(b)(6) 2012: the patient presented with ¿not at lot of strength¿ in the lower back and very limited range of motion in the right shoulder with pain.The patient was noted as having a combination of impediment syndrome, possible rotator cuff disease and a partial frozen shoulder.The patient also presented with osteoarthritis in the knee and hands.X-rays showed the fusion to ¿be healing nicely¿.(b)(6) 2012: the patient presented with the diagnosis of lumbago, osteoarthritis lower leg, and shoulder and upper arm sprain.The patient descries throbbing pain in the right shoulder a constant ache in the lower back with intermittent pain that traveled to the either thigh, and bilateral knee/hip pain.(b)(6) 2012: the patient presented with lumbar radiculopathy.(b)(6) 2012: the patient presented with shortness of breath worsening over the last few months, cough, and mild burning sensation of the lower back.An ekg showed normal sinus rhythm and no acute st or 1 wave changes.Breath sounds were diminished to bilateral lobes, to right middle lobe and bilateral lower lobes.(b)(6) 2012: the patient underwent an ekg which revealed a 5t-t abnormality and sinus bradycardia.(b)(6) 2012: the patient underwent x-rays which showed a slight tilt of the lumbar spine to the left.A growth stimulator was also present with the tip within the lower spinal canal adjacent to the coccygeal segments.Extensive osteoarthritis was noted involving the left-sided facet joints with extensive bone hypertrophy and joint space narrowing.The bones were osteopenic.There was however, no fracture.The disc spaces are slightly narrowed from l2 through l5.There was no spondylolisthesis or spondylolysis.(b)(6) 2012: the patient presented with some discomfort.The right shoulder was progressing significantly.The patient expressed that they wanted the ebi taken out.(b)(6) 2012: the patient presented with breathing difficulty.Active problems were listed as hypertension, asthma, hypercholesterolemia, arthritis, left bundle branch hemiblock and dyspnea.The patient was positive for back spasm, medications: oxycodone.The patient underwent an ekg which was abnormal.(b)(6) 2012: the patient presented with lumbago, balance problems, and back pain with prolong walking or standing.The patient ambulated with a cane.The patient also presented with the preoperative diagnosis of post laminectomy and fusion with ebi fusion stimulator.The patient underwent surgery which consisted of the removal of the ebi fusion stimulator.No patient complications were noted.(b)(6) 2012: x-rays revealed instrumentation appearing intact and fusion appeared to be consolidating well.(b)(6) 2012: the patient presented with adhesive capsulitis of the right shoulder and lumbago.(b)(6) 2012: the patient presented with osteoarthritis of the knee, low back pain, and degenerative disc disease.The patient also reported fatigue, difficulty sleeping, headaches, shortness of breath, wheezing, heartburn, chest pain, palpitations, joint stiffness, swelling, leg cramps, muscle pain, decreased range of motion, numbness, tingling, trouble walking, unsteadiness, depression and deep vein thrombosis.(b)(6) 2012: the patient presented with osteoarthritis of the knee.The patient complained of insidious bilateral medial and anterior knee pain.The patient underwent bilateral steroid injections.(b)(6) 2012: the patient presented with adhesive capsulitis of the right shoulder and lumbago.The patient reported back and joint pain.(b)(6) 2012: the patient presented with osteoarthritis of the knee and degenerative disc disease.The patient was 4 weeks status post corticosteroid bilateral knee injections and reported 50% improvement in the pain but still had persistent ¿burning¿ pain in the knees.The patient reported constant low back pain, radiating into the right and left lateral leg to the dorsum of the foot, aching and burning in nature.Medications: gabapentin and oxycodone.

Manufacturer Narrative

Concomitant medical products: fusion stimulator, spinal instrumentation (implant (b)(6) 2011).(b)(4).(b)(6).Neither the device nor applicable imaging study films 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/used 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.

• 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4246444
• MDR Text Key: 4989699
• Report Number: 1030489-2014-04376
• 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: 10/13/2014

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
• Device Expiration Date: 11/01/2013
• Device Catalogue Number: 7510800
• Device Lot Number: M111052AAF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2014
• Initial Date FDA Received: 11/12/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/14/2011
• 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): Required Intervention
• Patient Weight: 73