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

Catalog Number 7510100

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

Patient Problems Arthritis (1723); Dysphagia/ Odynophagia (1815); Headache (1880); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Swelling (2091); Dizziness (2194); Stenosis (2263); Injury (2348); Numbness (2415); Neck Pain (2433); Neck Stiffness (2434)

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) 2009, patient underwent spine fusion surgery on the cervical region of her spine from vertebrae c3 to c7.Reportedly, during the surgery, rhbmp-2 collagen sponge was used to fuse more than one level of the spine.Allegedly, post-operative period had been marked by a period of improvement, followed by progressively worsening and chronic neck pain, reduced mobility in neck, burning pain in her midback, loss of sensation in some of her fingers and areas of her arms, headaches, and difficulty swallowing.On (b)(6) 2014, the patient underwent revision surgery due to severe pain.These serious injuries prevent the patient from practicing and enjoying the activities of daily life that she enjoyed pre-operatively, and she has otherwise suffered serious and permanent injuries.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2009: the patient was preoperatively diagnosed with the cervical spondylosis with radiculopathy c3-c7 with kyphoscoliosis and underwent the following procedures: complex anterior cervical corpectomy c4.Complex anterior cervical corpectomy c5-c6.Complex anterior cervical discectomy additional levels c6-c7.Anterior cervical fusion c3-c4.Anterior cervical fusion additional levels c4-c5, c5-c6, c6-c7.Structural allo fibula plus extra small bmp grafting.Local autologous bone grafting.Microscope visualized corpectomy.Complex anterior cervical plating c3-c7 with a anterior cervical plate with variable angled screws at all levels.As per op-notes¿ we started out with anterior cervical disc fusions at c5-c6, c6-c7, did thorough discectomies and went down and thinned out the pll at both levels and then reconstructed with structural allofibula grafts that were stuffed with bmp and local autograft.We achieved hemostasis.We the turned our attention to c3-c4 and c4-c5 levels where we did a subtotal corpectomy on the right side.She had an anomalous vertebral artery that came into the vertebral body at c4 and that made this subtotal corpectomy more complex than usual.We thoroughly decompressed the foramen as well as the central canal at both of these levels and then took a structural allograft and packed this with local autograft along with the remaining bmp.The c4 corpectomy was then finished.We used the corpectomy bone to pack in the disk spaces on the left side at 3-4 and 4-5 and then achieved hemostasis.The patient tolerated the procedure well¿.No patient complications were reported.The patient also underwent cervical spine single view and 2 or 3 views due to degenerative disc disease, status post spinal fusion.Impression: interval instrumented anterior spinal fusion from c3 through c7.On (b)(6) 2009: the patient presented for an office visit after falling into a hole in her yard.The patient underwent cervical spine 2 views due to neck pain.Impression: instrumented anterior spinal fusion at c3-c7.On (b)(6) 2009: on a telephonic conversation, patient stated that she had swelling in her right biceps region.Patient also stated that she had a lot of pain and was unable to reach behind her back with the arm.On (b)(6) 2009: the patient presented for office visit due to muscle spasms.The patient underwent cervical spine 2 or 3 views due to c ervical spondylosis, cervical fusion.Impression: anterior decompression and instrumented fusion from c3 through c7, with c4 corpectomy.The bone grafts do not appear incorporated and there is persistent angular motion of the fused segments.On (b)(6) 2009: the patient presented for clunking sensation and terrible headache and also had numbness in left small finger.The patient underwent cervical spine 3 views with flexion and extension due to neck pain.Impression: there is a definite angular excrusion of the fused segments at c6-c7 with flexion and extension.On (b)(6) 2009: on a telephonic conversation, patient stated that since she had been wearing the collar she had noticed that her right shoulder and arm pain has increased.On (b)(6) 2009: the patient presented with right shoulder pain.On (b)(6) 2009: the patient presented for clunking sensation and terrible headache and also had numbness in left small finger.On (b)(6) 2009: the patient presented due to pain in right arm and hand.The patient underwent cervical spine 2 or 3 views due to neck pain.Impression: anterior spinal fusion at c3-c7 with continued angular excursion of the fused segments at c6-c7 with flexion and extension.On (b)(6) 2009: on a telephonic conversation, patient stated that she was in severe pain, unable to move her head to the right, swelling at the base of her neck and pain between shoulder blades.On (b)(6) 2010: on a telephonic conversation, the patient stated that she continued to feel bad while taking medrol dose pack.On (b)(6) 2010: the patient presented with right shoulder pain, some dizziness and some problems with balance and tripping.The patient underwent non-contrast ct of cervical spine with reconstructions due to radicular neck pain.Impression: lucent lines surrounding the disc spacer in the inferior portion of c5 and the inferior portion of c6.Degenerative changes.Postoperative changes from anterior spinal fusion of c3 through c7 with corpectomy of c4 and fibular strut grafting noted.The patient also underwent mri of cervical spine without contrast due to cervical spondylosis with anterior spinal fusion and neck pain.Impression: instrumented anterior spinal fusion procedure from c3-c7 with a c4 corpectomy and c5-c6 and c6-c7 discectomies.Anterolisthesis of c5 on c6 without central canal stenosis.No neural foraminal narrowing.The patient also underwent cervical spine minimum 4 views.Impression: c4 corpectomy and c5-c6 and c6-c7 discectomies with anterior instrumented fusion in near anatomic alignment.Mild left c4-c5 neural foraminal narrowing secondary to facet osteoarthritis.On (b)(6) 2010: the patient presented with some neck stiffness and a recent onset of mid to low back pain with numbness in the back of her legs and feet.The patient underwent cervical spine 2 or 3 views due to neck pain.Impression: postsurgical changes of anterior cervical discectomy and fusion procedure without motion at fused segments.Mild anterolistheis of c2 on c3 that reduces with extension.On (b)(6) 2010: the patient presented with some occipital headaches that had been going for a while.The patient underwent mri of cervical spine without contrast.Impression: stable, instrumented c3-c7 anterior cervical disc fusion.Stable c2-c3 and c7-t1 intervertebral disc appearance without interval desiccation or loss of height.No central canal or neural foraminal stenosis.Posterior ligament complex and facets appear normal except for mild facet arthropathy at c5-c6.Mild angular excursion was described on radiographs at c6-c7.The patient also underwent cervical spine with oblique/flexion/extension views due to cervical spondylosis.Impression: c3-c7 anterior cervical disc fusion procedure and c4 hemicorpectomy with strut graft.Motion at c6-c7 fusion site.Moderate cervical spondylosis, left is greater than right.S- shaped curvature of cervicothoracic spine.On (b)(6) 2011: the patient presented with some numbness in her hands and feet.The patient underwent cervical spine mri without contrast due to research study for spinal injury.Impression: anterior cervical discectomy and fusion from c3 through c7 with c4 corpectomy.No evidence of instrumentation failure.There are residual osteophytes at c5-c6 and c6-c7, resulting in mild central canal stenosis.Degenerative disease at c2-c3, c7-t1 and t3-t4.The patient also underwent cervical spine 2 or 3 views due to anterior cervical discectomy and fusion.Impression: anterior cervical discectomy and fusion of c3-c7 and c4 corpectomy with strut graft.There is persistent motion at the c6-c7 level, with interval breakage of one of the c7 screws.On (b)(6) 2012: the patient underwent cervical, thoracic and lumbar spine mri without and with contrast due to post cervical spinal fusion with widespread degenerative disease in spine and worsened neck pain.Impression: no change early degenerative changes of the cervical spine in the patient status post prior cervical spine fusion, with persistent degenerative disc disease at c2-c3 and c7 and t1, without central canal stenosis.Unchanged mild anterolisthesis of t11 on t12 with moderate bilateral facet arthropathy at this level.Multilevel degenerative changes of lumbar spine.On (b)(6) 2012: the patient presented with neck pain.The patient underwent x-ray of cervical spine.Impression: pseudoarthrosis at the c6-c7 level with broken screws.The patient presented for cervical spine 2 or 3 views due cervical spine degenerative disc disease.Impression: status post anterior cervical spine fusion procedure from c3 to c7 corpectomy of c4.Mild motion at c5-c6 with flexion and extension.On (b)(6) 2013: the patient presented with a complaint of new onset of about 4 month of difficulty swallowing meats and breads and difficulty in working with her arms overhead.The patient underwent cervical spine 3 views or less due to cervical spondylosis.Impression: unchanged anterior decompression and attempted instrumented fusion, c3-c7.Angular excursion at c6-c7 with flexion and extension indicated nonunion at this segment.On (b)(6) 2014: the patient underwent mri of cervical spine without contrast due to cervical spondylosis with radiculopathy and c3-c7 with kyphoscoliosis.Impression: redemonstrated are postsurgical changes of cervical spinal fusion with persistent degenerative disc disease at c2-c3, c5-c6 and c6-c7 with residual disc osteophyte complex at c5-c6 and mild left neural foraminal narrowing at c6-c7.The patient underwent cervical spine 3 views or less due to cervical spondylosis.Impression: unchanged anterior decompression and attempted instrumented fusion, c3-c7 with angular excursion at c6-c7 with flexion and extension.On (b)(6) 2014: the patient presented with a complaint of neck pain with pain radiating across her shoulders and headaches at the base of her skull.The patient underwent non-contrast ct of cervical spine with reconstructions due to radicular neck pain.Impression: postoperative changes of anterior instrumented fusion from c3 through c7 with failure of fusion at c6-c7 and fracture of the left vertebral body screw at c7.The remaining levels are solidly fused.Mild-to-moderate neuroforaminal stenosis throughout the cervical spine without significant central canal stenosis.The patient underwent cervical spine 3 views or less due to cervical spondylosis.Impression: unchanged anterior decompression and attempted instrumented fusion, c3-c7.Mild angular excursion at c6-c7 with flexion and extension is unchanged.Degenerative disc disease from c2 to c3.On (b)(6) 2014: the patient was preoperatively diagnosed with status post c4 corpectomy c5-c6 and c6-c7 anterior cervical disc fusion with pseudarthrosis c6-c7, adjacent segment pathology at c7-t1 with radiculopathy and underwent the following procedures: posterior cervical fusion c6-c7.Posterior cervical fusion additional level c7-t1.Posterior cervical segmental instrumentation c6-t1 with screws with lateral mass screws into c6-c7 and pedicle screws bilaterally into t1.Structural allo-iliac crest structural graft plus local autograft and demineralized bone matrix grafting.As per op-notes¿ we striped subperiosteum to expose c6-t1 and we decorticated the facets at c6-c7, c7-t1, packed in local allograft, demineralized bone matrix k to achieve fusion at c6-c7, c7-t1.We then put pedicle screws at t1 bilaterally with vertex selection instrumentation.After putting this we put a spinous process cable from c7 to t1 to lordose the spine further and then we took a structural iliac crest allo-cancellous iliac crest, cut it, and put one on left side between spinous process of c7-t1 and another one on the right side between c7 and t1.We added additional can-pak, fresh frozen allograft, local autograft, demineralized bone matrix over decorticated lamina of c7 and t1.The patient tolerated the procedure well¿.The patient presented for cervical spine 3 or less view due to cervical nonunion.Impression: new laminectomies and posterior instrumented fusion, c6-t1.On (b)(6) 2014: on a telephonic conversation, patient¿s mother stated that the patient was still having a lot of pain and the patient had a white coating over tongue and tongue is very sensitive to any sort of foods.On (b)(6) 2014: on a telephonic conversation, patient¿s mom told about the drainage from the incision.On (b)(6) 2014: the patient presented for follow up visit.The patient underwent x-ray of cervical spine.Impression: pseudoarthrosis at the c6-c7 level with adjacent segment pathology at the c7-t1 level.The patient underwent cervical spine 3 views or less due to cervical spondylosis.Impression: unchanged c4 corpectomy with anterior instrumented fusion, c3-c7 and posterior instrumented fusion from c6-t1.There is no motion at fused levels.Degenerative spur at c2-c3.On (b)(6) 2014: on a telephonic conversation, patient complained about a knot just above the level of the top the posterior incision that is painful to touch.On (b)(6) 2014: the patient presented with complaints of some burning type pain on the right side of her mid-back and a localized pain across her shoulder blades to touch.The patient underwent x-ray of spine.Impression: cervicalgia.The patient underwent cervical spine 3 views or less due to cervical spondylosis.Impression: unchanged anterior decompression and instrumented anterior fusion, c3-c7 with c4 corpectomy and posterior instrumented fusion from c6-t1.There is no motion at fused levels.On (b)(6) 2015: the patient underwent cervical spine 3 views or less due to cervical spondylosis and cervical fusion.Impression: unchanged partial c4 corpectomy with anterior discectomy and instrument fusion, c3-c7 and posterior instrumented fusion from c6-t1.No motion of fused levels between flexion and extension.

• 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: 5404826
• MDR Text Key: 37308298
• Report Number: 1030489-2016-00379
• 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,Followup
• Report Date: 04/21/2016

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: 03/31/2010
• Device Catalogue Number: 7510100
• Device Lot Number: M110814AAI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2016
• Initial Date FDA Received: 02/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/19/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2009
• 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: 104