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

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

Patient Problems Neuropathy (1983); Pain (1994); Swelling (2091); Tingling (2171); Stenosis (2263); Anxiety (2328); Depression (2361); Numbness (2415); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4); notes: 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 manufacturer 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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on: (b)(6) 2008: the patient was presented with painful implantation, nonunion from l4-s1, left l4 to s1 foraminal stenosis and underwent exploration of previous mass and removal of previous rod and legacy screws from l4-s1.Repair of nonunion at the level of l5-s1 using graft and bmp.Instrumentation of l4-s1 using legacy pedicle screw and rod.Posterior decompression with foraminotomy of l4-5 and l5-s1 in the left side.Indications: patient complains of intractable low back pain with radiation down towards his lower extremities, left worse than right.Patient is status post transforaminal inter-body fusion and instrumentation at l4-s1.Patient was diagnosed with painful hardware versus non union.Procedure description: using bovie and cobb elevator, the muscles were reflected from the spinous processes, lamina, facet joints and previous implanted bilaterally.The screws at l4 and l5 were completely rigid but the screws at this one were loose.After removal of screws, the incision was irrigated copiously.Using 45 mm in length and 7.5 mm in diameter, the screw inserted at the pedicle of s1 bilaterally and 7 mm in diameter and 55 mm in length at the pedicle of l4.There was no sign of non union at the level of l4-l5.At the level of l5-s1 there was obvious motion.Foraminotomy at l4-l5 and l5-s1 was performed.Decompression accomplished and then two pieces of rod were inserted on top of screws and tightened.Sacral ala and transverse process of l4 sacral area were decorticated.The graft matrix and bmp impacted between l4 to s1 sacral ala bilaterally.The patient tolerated the procedure well and was sent in satisfactory to the recovery room.On (b)(6) 2008: patient presented with increase in his lower back pain and pain in his abdomen and testicle.Patient underwent ct scan with ultrasound of testicle which was non conclusive.Ap lateral flexion/extension of lumbar spine show that position of instrumentation is intact.There is no sign of loosening of screws.On (b)(6) 2011: the patient underwent mri of lumbar spine due to low back pain.Pain and swelling and numbness in the right leg and right foot pain with tingling.Tingling in left leg.Impression: postoperative changes at the l4-l5 and s1 levels.The right and left pedicles appear to have been surgically removed at the l5 level.Small posterior left paracentral, left foraminal disc protrusion at the l3-l4 level causing narrowing of the left intervertebral neural foramina at the l3-l4 level.On (b)(6) 2013: patient presented with preoperative diagnosis of adjacent disk disease, juxtafusion discopathy of l3-l4; spinal and foraminal stenosis of l3-l4 and segmental instability of l3-l4,status post previous lumbar fusion of l4-s1;right sided foraminal stenosis of l3-s1 and underwent exploration of previous surgical area; removal of set screw and rod bilaterally.The pedicle screws at l4 and s1 were completely rigid and tight and the fusion was completely solid.Posterior decompression and bilateral foraminotomy of l3-l4.Transforaminal interbody fusion of l3-l4 using local autogenous bone graft, cancellous allograft, bone marrow aspirate with implantation of a peek spacer with 12-mm height, packed with local autogenous bone graft using the medtronic system.Segmental pedicle screw instrumentation of l3 using legacy titanium pedicle screws at the level of l3.Posterior spinal fusion of l3-l4 using local autogenous bone graft, cancellous allograft, bone marrow aspirate, and putting a rod from l3, l4, and s1.Right-sided hemilaminectomy of l5, decompression of right s1, l5, l4, and l3 nerve root and inter transverse arthrodesis of l3-previous fusion mass using local autogenous bone graft, cancellous allograft, and bone marrow aspirate.Procedure description: two 6.5 x 50 mm legacy screw was inserted in pedicle of l3.A spacer with 12 mm height packed with local autogenous bone graft was implanted between the body of l3-l4.On (b)(6) 2013: patient presented for office visit.X-ray of lumbar spine is normal and sagittal alignment of lumbar spine is normal.Impression: spinal stenosis lumbar.On (b)(6) 2014: patient presents with low back pain and right leg pain.Review of systems: musculoskeletal: complains of back pain and stiffness.X-ray of lumbar spine is demonstrating spinal fusion of l3-s1 ,sign of dislodgement of left set screw competitive it possible nonunion.Impression: ddd of lumbar spine.On (b)(6) 2014: the patient underwent ct of lumbar spine.Impressions: status post anterior and posterior fusion procedure from l3-4 through l5-s1.There is mild impingement on the foramina due to spurring.Facets joints are fused.On (b)(6) 2014: patient underwent x-ray of chest.Impression: no acute cardiopulmonary disease.On (b)(6) 2014: the patient was presented with dislodgement of set screw from the rod and pedicle screw on the left side at the level of l3, right s1 and l3 radiculopathy.Patient presented with pre operative diagnosis of painful implantation, dislodgement of set screw from the rod and pedicle screw on the left side at the level of l3,right s1 and l3 radiculopathy and underwent following procedures exploration of previous surgical area.Removal of set screws x3, rods x2 and pedicel screws x6.The fusion was found solid without any motion at the area of the previous surgery.Partial laminotomy and decompression of right s1 nerve root and partial laminotomy of l5 and s1.Partial laminectomy of l3 with decompression of right l3 nerve root.Procedure description: the set screws were removed from the right side.Subsequently, the set screw from l4 and s1 was removed and the set screw from l3 was embedded inside the soft tissue.The set screw was removed.There was some corrosion and dark tissue surrounding that area which was taken out.All of the pedicle screw were rigid and tight and were taken out.A partial laminotomy of l5-s1 was done, decompression of the right s1 nerve root was performed on the l3 area and a partial laminotomy was performed.A foraminotomy and decompression of the right l3 nerve root was performed.Patient tolerated the procedure well.Patient alleged " must now use a knee and back brace in order to ambulate.He also suffered from a neurogenic bladder and sexual d ys function.Requires assistance with daily activities and suffer from serious depression.".

Event Description

It was reported that on (b)(6) 2008, the patient underwent posterolateral fusion from vertebrae l4 to s1.The patient was implanted with rhbmp-2/acs in this surgery.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the lateral gutters).Allegedly, post-op, "the patient continues to experience chronic lower back pain, with pain radiating to his hips and legs, and numbness and tingling in his legs.He is unable to sit, stand or walk for any extended period.If he attempts any household chores, he is bedridden for one to two days.Patient also suffers from sexual dysfunction and anxiety.".

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.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; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6029435
• MDR Text Key: 57420147
• Report Number: 1030489-2016-02893
• 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,Followup
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2017
• 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: 118