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(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.Products from multiple manufacturers were implanted 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.
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It was reported that on (b)(6)-2005: the patient was involved in a motor vehicle accident.The patient sustained multiple traumas including left rib fractures.(b)(6)-2005: the patient presented for x-rays of the cervical spine.Impression: degenerative disc disease at c5-6; narrowing of the disc space and posterior bony spur formation.The patient also underwent x-rays of the lumbar spine.Impression: mild narrowing of the disc space at l5-s1 due to degenerative disc disease.(b)(6)-2005: the patient underwent x-ray of the lumbosacral spine without contrast.Impression: degenerative change l5-s1 with a mild diffuse disc extrusion, slightly more pronounced on the right where it does abut upon the right s1 root, without displacement, there may be some right s1 irritation; a small right sided lateral l4-5 disc protrusion is identified with mild nerve root compression at the foraminal level.(b)(6)-2005: the patient presented with episodic headaches, neck pain radiating down to sides.He has pain about the left ear.He has pain in the right shoulder when lifting the arm upwards and has lost some strength in hands.Impression: subacute cervical sprain and strain; subacute thoracic sprain and strain; subacute lumbosacral sprain and strain; cervical radiculopathy; lumbosacral radiculopathy; internal derangement of the right knee; post-traumatic stress disorder; tension headaches.(b)(6)-2006: the patient presented with cervicalgia with right shoulder radiation and perceived weakness in both upper extremities.Cervical range of motion potentiates pain.The low back pain is associated with radiation across the left buttock and to the left thigh with pain potentiated by weight bearing ambulating and lumbar range of motion activities.Mri of the cervical spine reveals a herniated nucleus pulposus with superimposed spondylosis at c5-6.Mri of the lumbar spine reveals a herniated nucleus pulposus at l5-s1.Impression: post-traumatic cervicalgia with right cervical radiculopathy; herniated nucleus pulposus with superimposed spondylosis c5-6; post-traumatic low back pain with left lumbosacral radiculopathy; herniated nucleus pulposus l5-s1.(b)(6) -2006: the patient presented with cervicalgia with trapezius and left scapular radiation, as well as perceived weakness in the right hand as well as low back pain which extends to the left buttock with no distal radicular pain.The patient has undergone epidural steroid injections as well as lumbar facet injections.The patient has loss of cervical range of motion with point tenderness at the c5-6 level with localized muscular spasm.Lumbar exam reveals anterior flexion restricted to 30 degrees with bilateral lumbosacral point tenderness with muscular spasm.Straight leg raising generates low back pain.(b)(6) -2006: the patient presented with low back pain.The patient has pain on range of motion of his lumbosacral spine with ongoing sitting intolerance.Diagnoses: lumbar radiculopathy responsive to lumbar epidural steroid injections times three treatments with relief of his lower extremity pain with persistent low back pain; herniated disc at l5-s1 with extrusion with right s1 nerve root impingement; lumbar facet arthropathy posttraumatic right sided predominant treated with lumbar facet injections with persistant low back pain; lumbar myofascial pain syndrome with spasticity; cervical discogenic pain with a herniated disc at c5-6; cervicalgia with cervical and trapezius myofascial pain.(b)(6) -2006 : the patient presented for ct of the lumbar spine.L4-5, there is a right sided small foraminal disc protrusion.This is encroaching on the exiting l4 nerve root on the right.The left neural foramen and canal are remarkable.L5-s1 shows disc space narrowing.There is posterior and posterior lateral spurring associated with a chronic shallow disc protrusion.This causes mild degree of canal narrowing although no evidence of any neural encroachment.The patient also underwent ct of the cervical spine.At c3-4 there is a tiny central disc protrusion.At c5-6 there is broad uncinated spurring bilaterally and symmetrically.There is mild canal narrowing with some minimal effacement of the anterior thecal sac.The neural foramina are only minimally encroached upon.(b)(6) -2006: the patient presented with cervicalgia with bilateral dorsal upper extremity radicular pain as well as low back pain with left ventral thigh radiation with the predominate pain axial in nature.(b)(6) -2006: the patient underwent a provocative lumbar discography at l1-2, l2-3, l3-4, l4-5, and l5-s1 under fluoroscopic imaging.Results: positive l5-s1 discogenic pain with concordance.(b)(6)-2006: the patient presented for ct scan of the lumbar spine.Impression: there is a grade iv at l4-5 on the right side.Disc protrusion is seen at this level; posterior inferior bony spur at l5; small elft disc protrusion at l5-s1 on the left side; the facet joints are normal.(b)(6)-2006: the patient presented with low back pain.There is periodic left proximal lower extremity radicular pain, thought he vast majority of the pain is axial in nature.Lumbar examination reveals anterior flexion restricted to 45 degrees with pain on deflexion.There is bilateral lower lumbar and lumbosacral point tenderness with paravertebral muscular spasm.Neurological exam revealed bilaterally antalgic gait with stooped posture.Prior lumbar myelogram and post myelographic ct scanning had revealed a right foraminal protrusion at the l4-5 level and a broad disc protrusion at the l5-s1 level.The post discography ct shows a rightward herniation at the l4-5 level with a grade 5 internal disco disruptions in the region of the previously noted discogenic herniation.(b)(6)-2006: the patient presented with low back pain with left radicular pain with axial pain of greater intensity than the radicular component.The patient wishes to proceed with operative intervention.(b)(6)-2006 : the patient presented with preoperative diagnoses of l4-5 and l5-s1 herniated nucleus pulposus and internal disk disruption, with painful lumbar discogenic syndrome of l5,s1.The patient underwent the following procedures: l4-5 and l5-s1 laminectomies; bilateral l4-5 and bilateral l5-s1 discectomies and posterior lumbar interbody arthrodesis with implantation of peek interbody prosthetics; l4-s1 segmental instrumentation with pediculous screw fixation; l4-s1 posterolateral arthrodesis; image guided computer assisted stereotactic navigation to assist in instrumentation placement; posterior single incision 360 degree lumbosacral instrumented arthrodesis; utilization of rhbmp-2/acs in conjunction with local bone for both interbody arthrodesis and posterolateral arthrodesis.Per the op notes, the 12mm x 22mm peek telamon cages (4) were filled with rhbmp-2/acs.These prosthetics were bilaterally tamped and countersunk into position at both l4-5 and l5-s1.The instrumentation system chosen was the tsrh 3d pedicle screw system.The pedicle screws chosen were 6.5 mm in diameter by 40 mm in length at l4 and l5 and 7.5 mm in diameter by 35 mm in length at s1.Following instrumentation, the posterolateral beds were then packed with local mastergraft and rhbmp-2/acs to allow for bilateral posterolateral arthrodesis.No intraoperative complications were noted.(b)(6)-2006: the patient was evaluated by an infectious disease doctor.Impression: right upper lobe pneumonia, community-acquired versus hospital acquired.He is right at that cusp: status post posterior lumbar interbody fusion.(b)(6)-2006: the patient was discharged home.Per the discharge notes, the patient developed pneumonia during his hospital stay.(b)(6)-2007: the patient presented with low back pain with bilateral radicular pain.He ambulates with a rolling walker with a rigid orthotic.(b)(6)-2007: the patient presented with diminishing low back pain and lower extremity dysesthesias.He remains in the rigid lumbosacral orthotics.(b)(6)-2007; the patient underwent epidural steroid injection at c5-6.(b)(6)-2007: the patient presented stating his pain has been diminishing.Neurological exam reveals mildy antalgic gait through impr oved relative to his preoperative status.Repeat x-rays reveal satisfactory prosthetic position, instrumentation position and spinal alignment.(b)(6)-2010: the patient presented for x-rays of the cervical spine.Impression: degenerative changes with degenerative disc disease; bony demineralization; no obvious bony injury is seen.(b)(6)-2010: the patient presented with chronic neck pain and chronic low back pain.He has been permanently disabled for two years.He reports falling five weeks back and states it did worsen his pain in both regions.He describes cervicalgia with right dorsal radicular pain to the hand as well as low back pain with right buttock extension.Cervical exam reveals moderate restriction of range of motion with right posterolateral point tenderness.Thoracolumbosacral exam reveals anterior flexion restricted to 45 degrees with well healed incision with right paramedian lower lumbar point tenderness.(b)(6)-2010: the patient underwent mri of the cervical and lumbar spine.There is spondylosis at c3-4 and c4-5.There is spondylosis with superimposed bulge and small central disc herniation at c5-6.There is sponylosis with superimposed left paracentral disc herniation at c6-7.In the lumbar region, there are postsurgical changes with evidence of instrumented arthrodesis at l4-5 and l5-s1 with mild bulging disc annulus at l3-4.(b)(6)-2010: the patient presented with cervicalgia with bilateral upper extremity radicular pain as well as low back pain with right buttock extension and periodic right lower extremity radicular pain.Cervical examination found moderate restriction of range of motion with bilateral paramedian point tenderness.There is bilateral lower lumbar point tenderness.(b)(6)-2010: the patient presented with back pain and stiffness with intermittent leg pain.He also experiences neck pain with intermittent numbness and tingling in his upper extremities.He also reports occasional spasms in his neck.He experiences right shoulder pain with some restriction on rangeof motion of the right shoulder with pain reported over the anterior shoulder and posterior neck along the midline.Diagnosis: chronic cervical radiculopathy with intermittent upper extremity radicular pain reported with history of central herniated disc at c5-6 and central and left lateralizing herniated disc at c6-7 with the majority of his symptoms being bilateral; right shoulder pain; chronic low back pain status post posterior lumbar fusion at l4-5 and l5-s1 with laminectomy and discectomy performed (b)(6) 2006; lumbago.
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Per medical record: on (b)(6) 2006 the patient underwent posterior lumbar interbody fusion (plif) at l4-s1 in which rhbmp-2/acs, spacer, bonegraft matrix, screws, double hex break off screws, pre-cut rods, small connectors, and crosslink were used.
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