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

Device Problems Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problems Dyspnea (1816); Edema (1820); Muscle Weakness (1967); Neuropathy (1983); Weakness (2145); Dysphasia (2195); Stenosis (2263); Joint Swelling (2356); Neck Pain (2433); Ambulation Difficulties (2544)

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 that: on (b)(6) 2013, the patient underwent an anterior cervical discectomy and fusion using rhbmp-2/acs at the c5 vertebra in order to relieve pressure on patient's spinal cord.X-ray images of spine showed that the anterior plate malfunctioned within the first 10 days of surgery.The bottom portion of the plate shifted and appeared malaligned anteriorly causing the prongs of the top portion to come out of the sockets on the bottom portion.His condition began to deteriorate.He had difficulty swallowing.His breathing became labored and difficult.He suffered deterioration of balance.His speech became slurred and stuttering and continued to degrade to the point where he nearly lost his ability to speak.He developed weakness on both sides of his body in addition to the weakness he already suffered on his right side.On (b)(6) 2013 the patient was presented for office visit with neck pain and back pain.Clinical impressions: exacerbation of chronic neck and back pain.The patient underwent ct scan for cervical spine.Impressions: surgical changes were described without evidence of complications.Degenerative disc disease.On (b)(6) 2014 the patient was presented for office visit with weakness, paresthesia and impaired speech.Patient underwent ct scan for cervical spine.Impressions: 1) post-surgical changes at the c4 through 6 levels once again noted, metallic beam artifact at these levels limits assessment.2) cervical spondylosis with neural foraminal narrowing.Spinal stenosis at the c4 level related to retrolisthesis of c4 and degenerative changes.3) bilateral maxillary sinusitis.The patient also underwent ct scan of the head.No complications were reported.On (b)(6) 2014, the patient presented for office visit.On (b)(6) 2014, as a result of the anterior plate's failure, patient's spine failed to fuse, so emergency surgery was performed.Post-op diagnosis: cervical instability and stenosis.On (b)(6) 2014, the patient was discharged.On an unknown date, post-op his revision surgery, the physical condition had decreased further since the restorative surgery on.As a result, his legs did not support his weight and he required the assistance of a walker; he had limited use of his hands; and he had a limited ability to speak.He had developed severe depression.He had developed erectile dysfunction.

Event Description

It was reported in a complaint from patient's attorney that on (b)(6) 2013, the patient underwent an anterior cervical discectomy and fusion using rhbmp-2/acs at the c5 vertebra in order to relieve pressure on patient's spinal cord.It is alleged that x-ray images of spine showed that the anterior plate malfunctioned within the first 10 days of surgery and that the bottom portion of the plate shifted and appeared malaligned anteriorly causing the prongs of the top portion to come out of the sockets on the bottom portion.It is further alleged that the patient's condition began to deteriorate and that he had difficulty swallowing, his breathing became labored and difficult, and he suffered deterioration of balance; his speech became slurred and stuttering and continued to degrade to the point where he nearly lost his ability to speak; he developed weakness on both sides of his body in addition to the weakness he already suffered on his right side.It is further alleged that on (b)(6) 2014, as a result of the anterior plate's failure, patient's spine failed to fuse, so emergency surgery was performed.It is further alleged that post-op the revision surgery, the patient's physical condition had decreased further since the restorative surgery on and as a result, his legs did not support his weight and he required the assistance of a walker; he had limited use of his hands; limited ability to speak; developed severe depression; developed erectile dysfunction.Information reported by the implanting surgeon indicates that x-rays initially showed slight dislodgment of the plate, but the plate did not break or become unstable.Additional workup including flexion/extension studies and ct scans showed no changes in the alignment or any signs of instability.The surgeon felt the plate was functioning properly and that there was no need to revise the instrumentation.The surgeon also confirms that rhbmp-2 was not used to treat this patient.A review of the implant log included in the patient's medical records also indicates no use of rhbmp-2.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2013, patient presented for office visit to establish pcp.Patient reported muscle weakness and muscle atrophy on the right side of the body.On (b)(6) 2013, patient presented for office visit.Patient underwent x-ray of cervical spine.Impression: post surgical cervical spine with some degenerative changes noted.On (b)(6) 2013, patient presented for follow-up due to right peripheral neuropathy and deteriorating bone disease in neck.On (b)(6) 2013, patient presented for office visit due to continued weakness, pain and muscle deterioration.On (b)(6) 2013, patient presented for office visit due to neck pain.Patient had a fall at home and was very weak with unsteady gait.Patient was ambulating with cane.Patient underwent x-ray of neck.Impression: the spine shows surgical intervention of c4-5.Slight degenerative changes seen above and below the surgically treated area.There does not appear to be any acute changes on this x-ray.Old surgical intervention was noted.On (b)(6) 2013, patient presented for office visit due to peripheral neuropathy to his feet and legs.On (b)(6) 2014, patient presented for office visit and was diagnosed with muscle weakness, decreased sensation and neck pain.On (b)(6) 2014, patient presented for office visit.Patient reported continued neck pain, right leg pain, frequent falls and worsening right sided weakness.On (b)(6) 2014, patient was discharged with following diagnosis: cervical myelopathy, status post posterior decompressive cervical laminectomy at c4 through c6 with lateral mass screws and arthrodesis; postoperative anemia.On (b)(6) 2014, patient presented for office visit due to nausea, diarrhea, abdominal cramps and watery bowel movements.On (b)(6) 2014, patient presented for office visit due to complaints of swollen and painful right hand joints.On (b)(6) 2014, patient presented for office visit for follow-up on neck pain.Patient reported continued difficulty in ambulation.On (b)(6) 2014, patient presented for office visit due to left sided rib pain, neck pain and fall.Patient underwent x-ray of left ribs.Impression: alignment and spacing of the left ribs are within normal limits.No obvious fracture seen of the left ribs series.Patient underwent x-ray of cervical spine.Impression: rods and clips into the cervical spine.This involves c3-c5.Of course degenerative changes are seen throughout this area.There was no new, obvious abnormality seen around the previous surgical intervention.On (b)(6) 2014, patient presented for office visit due to complaint of low back pain and recurrent falls.Patient underwent x-ray of lumbar spine.Impression: both the ap and lateral views of the lumbar spine show normal alignment and spacing.No acute abnormality seen on this x-ray.Patient underwent x-ray of thoracic spine.Impression: normal alignment and spacing on both the ap and lateral views of the thoracic spine.No acute abnormality seen.On (b)(6) 2014, patient presented for office visit due to low back pain.Patient reported having a fall.Patient underwent lumbar x-ray.Impression: ap and lateral views of the lumbar spine do not show any acute abnormalities at this time.Patient underwent x-ray of cervical spine.Impression: marked surgical intervention in the past, particularly c3-6.Degenerative changes seen on the lateral view with early spur formation.This x-ray does not show any abnormality that would be assumed to be acute from this surgical intervention.The surgeon cannot see any abnormality related to the old surgical repair.On (b)(6) 2014, patient presented for office visit for chronic pain, frequent falls and medication refill.On (b)(6) 2014, patient underwent x-ray of chest.Impression: mild central vascular congestion.No evidence of confluent pulmonary in filtrates or pleural effusions or a pneumothorax; no evidence of displaced fractures seen; suspected air-trapping disease.Patient underwent head brain without iv contrast.Impression: intracranial bleeding with fracture of the right mastoid.Surgical changes of the cervical spine with no acute findings.Patient underwent ct of cervical spine without contrast.Impression: intracranial bleeding with fracture of the right mastoid.Surgical changes of the cervical spine with no acute findings.On (b)(6) 2014 patient underwent x-ray of chest.Impression: no acute cardiopulmonary process was noted.Interval changes in both apices was suspected.Patient underwent ct of temporal bone without iv contrast.Impression: right temporal bone fractures.On (b)(6) 2014, patient was admitted for chief complaint of debility, status post subdural hemorrhage.On (b)(6) 2014, patient was discharged from hospital.On (b)(6) 2014, patient presented for medication review and refill.On (b)(6) 2014, (b)(6) 2015, patient presented for office visit due to complaint of frequent falls.Patient was using walker and wheelchair for ambulation due to frequent falls.On (b)(6) 2015, patient presented for office visit for follow-up on neck pain.On (b)(6) 2015, patient presented for office visit due to complaint of chronic pain.On (b)(6) 2015, patient presented for office visit due to complaints of weakness on right side of body.On (b)(6) 2015, patient presented with chief complaint of neck and back pain.On (b)(6) 2015, patient presented for office visit due to chief complaint of neck and back pain which are chronic in nature.Patient reported ambulating with walker.

• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5053601
• MDR Text Key: 24980747
• Report Number: 1030489-2015-02203
• 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
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2016
• 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): Required Intervention
• Patient Weight: 58