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

Catalog Number 7510200

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

Patient Problems Chest Pain (1776); Pain (1994); Weakness (2145); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).

Event Description

It was reported that on: (b)(6) 2011: the patient presented with pre-op diagnosis of l5-s1 spondylolisthesis with hypermobility and underwent following procedures: l5-s1 bilateral facetectomy, foraminotomy, gill procedure.Reduction of l5-s1 spondylolisthesis.Posterior lateral fusion l4-5 <(>&<)> l5-s1 with osteocell, autograft and bmp.Interbody anterior fusion l4-5 <(>&<)> l5-s1 with osteocell and bmp.Placement of intervertebral biomechanical device l4-5 <(>&<)> l5-s1 peek cage.Posterior segmental instrumentation of pedicle screws, rods, cross connectors; three segments.Harvest of local autograft.Per op-notes, ".At l4-l5 , the disk space was cleared out and then appropriate sized interbody graft was packed with bmp , autogrfat and osteocell and tapped into place under lateral fluoroscopic image.Attention was now turned to l5-s1 level where the disk space was opened.Interbody graft was tapped into place there, packed with autograft, bmp and osteocell.Osteocell, autograft and bmp were then packed along the rods bilaterally for the posterior fusion."(b)(6) 2011, the patient was discharged home.(b)(6) 2011, the patient presented for post㏐ follow up visit.(b)(6) 2011, the patient presented for follow up and underwent lumbar spine x-ray.Findings: no hardware failures.(b)(6) 2013: patient presented for an office visit.(b)(6) 2013: patient presented for an office visit and was diagnosed with thoracic or lumbosacral neuritis or radiculitis, unspecified.(b)(6) 2013: patient presented with continued pain in lower back, radiating to left leg; and underwent lumbar puncture with fluoroscopic guidance, followed by ct myelogram of the lumbar spine with transverse, sagittal, and coronal reformatted images.Comparison was made with mri lumbar spine, dated (b)(6) 2012.Impression: post-operative changes lower lumbar spine from l4-s1 with intervertebral disc spacers at l4 and l5 with anterolisthesis of l5 on s1, stable as compared to the prior studies.Severe left l5-s1 and moderate left l4-l5 neural foraminal stenosis due to post-operative hypertrophic changes, facet anthropathy, and posterior endplate spurring.No significant central canal or other neural foraminal stenosis is identified.Evaluation of the thecal sac from l2 through l4 is limited due to poor mixing of contrast with csf in this area on the ct, however, this area is fairly well seen on the plain film myelogram from same date and demonstrates no significant abnormalities.The patient underwent x-ray myelography lumbar spine.(b)(6) 2013: patient presented for evaluation of his low back pain.His imaging was reviewed which included a ct myelogram which showed pseudoarthrosis at the l4-l5 and l5-s1 levels with some haloing around the screws at l4 and s1.(b)(6) 2013: patient presented for an office visit and was diagnosed with pseudoarthrosis of the lumbar spine.(b)(6) 2013: patient presented for pre-operative evaluation assessment.Impression: the proposed surgical procedure is considered intermediate risk.No serious cardiac risks.(b)(6) 2013: patient presented for pre-operative visit and underwent anesthetic evaluation.Patient underwent pac for risk assessment and optimization of anesthesia with comorbid conditions of smoker and long duration of surgery.(b)(6) 2013: patient, who had a past medical history significant for a prior l4-s1 posterolateral instrumentation and fusion due to lumbar instability secondary to an automobile crash in (b)(6) 2011, got admitted in hospital with the following pre-op diagnosis: pseudoarthrosis at the l4-l5 and l5-s1 levels status post prior l4-s1 posterolateral fusion in 2011.The patient underwent the following procedures: removal of prior l4-s1 instrumentation.Placement of new l4-s1 posterolateral instrumentation.Redo l4-l5 tlif.Left foraminotomy at l4-l5 and l5-s1.Harvest of local autograft.Allograft redo posterolateral fusion from l4-s1.Use of intra-operative fluoroscopy.Use of intraoperative neuromonitoring with ssep and motor evoked potentials.The following implants were implanted into the patient, during the surgery: left l4 pedicle screw 8.5x50 mm; right l4 pedicle screw 8.5x55 mm left l5 pedicle screw 5.5x55 mm; right l4 pedicle screw 6.5x55 mm left s1 pedicle screw measuring 9.5x50 mm; right s1 pedicle screw 8.5x50 mm one crosslink at the l5-s1 level fifty-five mm titanium rods (x2) 6) thirty ml of crushed cancellous bone and 1x5 cm bone graft (x2) 7) locally harvested autograft per op-notes, "using the universal instrument removal system, we were able to remove the crosslinks as well as the screw caps, the rods as well as all of the pedicle screws from l4 through s1.We then turned our attention to placement of the new instrumentation.We first focused at the left s1 level.Unfortunately, at this level, during the insertion of the new pedicle screw, the screw itself fractured at the tulip head.Consequently, the screw was removed and was placed with a new s1 pedicle screw of slightly shorter length.Once the instrumentation portion of the operation was completed, intraoperative fluoroscopic x-ray was obtained to ensure that we obtained appropriate placement of the new pedicle screws.Once enough of the spacer was removed, we were able to insert new autograft and allograft into the intervertebral disk space at the l4-l5 level.No intra-operative complications were reported.(b)(6) 2013: patient complained of pain from surgery and chest pain.X-ray of lumbar spine (2-3 views), gave the following impression: combined anterior and posterior instrumented fusion from l4-s1, with the pedicle screws not significantly changed in appearance in the interval; the cross-link has been revised.Anterolisthesis of l5 on s1 is unchanged.(b)(6) 2013: patient was discharged from the hospital.(b)(6) 2013: patient underwent x-ray of lumbar spine (2-3 views).(b)(6) 2013: patient presented for post-op follow up.Patient complained hearing popping noises in his back, accompanied with some discomfort.As reported, his hardware looked good and incision well-healed.(b)(6) 2013: patient presented for a 3-month post-op follow up, regarding his posterior l4-s1 fusion and redo of a tlif and nerve root decompression surgery.He complained of still having some residual back pain along with some left lower extremity weakness.His earlier images showed stable instrumentation with no sign of loosening.(b)(6) 2013, the patient was admitted due to fall followed by pain and trauma and underwent chest x-ray.Impression: no acute cardiopulmonary process.The patient underwent pelvis x-ray.Impression: stable instrumented fusion changes from l4-s1.No acute osseous abnormality of the pelvis.The patient underwent head ct scan.Impression: no acute intracranial pathology.The patient underwent ct of cervical spine, thoracic spine and lumbar spine.Impression: no evidence of fracture and spinal canal or neural foraminal stenosis.Impression - lumbar spine: posterior instrumented fusion from l4-s1, persistent anterolisthesis of l5 on s1.No evidence for hardware failure or fracture.Multilevel degenerative changes most pronounced at l4-5 and l5-s1.No significant change since (b)(6) 2013.The patient also underwent mri of spine.(b)(6)2014, the patient presented with diagnosis of lumbar compression fracture, with routine healing, subsequent encounter and requested for re-examination.(b)(6) 2014, the patient presented with diagnosis of t12 vertebral fracture, seqela and arthrodesis status.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on, (b)(6) 2011: patient underwent x-ray of lumbar spine.Findings: seven intraoperative views of the lumbar spine demonstrate posterior rod and screw fixation of l4 to the sacrum.Interbody spacers were present.On (b)(6) 2011: patient presented for evaluation for possible cellulitis.On (b)(6) 2011: patient presented for follow-up.On (b)(6) 2012: as per billing records, patient underwent thoracic spine 3 views, lumbosacral spine 2-3 views.On (b)(6) 2012: patient underwent x-ray of lumbar spine due to indication of low back pain and bilateral leg pain.Findings: there was grade 2/4 spondylolisthesis at the l5-s1 level.There was no evidence to suggest endplate destruction/diskitis.Patient also underwent x-ray of thoracic spine due to back pain.Findings: there was mild dextroscoliosis without significant rotatory component.There was no evidence of vertebral body compression or subluxation.There was no evidence of diskitis or paravertebral soft tissue swelling.On (b)(6) 2012: patient underwent mri of lumbar spine with and without contrast.Impression: grade i anterolisthesis at l5-s1, posterior fusion l4-s1, with small right central l4-5 disk protrusion.On (b)(6) 2013: patient underwent ct of lumbar spine without contrast.Impression: status post l4-s1 bilateral transpedicular screw fixation and l4-l5 disk space cage/spacer placement.Minimal to mild lucency around the s1 screws is felt to represent beam-hardening artifact.However, strictly speaking, early loosening cannot be fully excluded in appropriate setting.There was no hardware fracture and the hardware alignment is appropriate.No osseous fusion across the disk spaces or posterior elements at the surgical device.Grossly unchanged grade 2 spondylolisthesis of l5 on s1.Possible mass effect upon the right exiting l4 nerve root at l4-5 neural foramen.On (b)(6) 2013: patient underwent x-ray of lumbar spine due to neck pain.Impression: there was no scoliosis.The hardware was intact and in appropriate alignment.There was grade 2 spondylolisthesis of l5 on s1 that improve upon extension but remains grade 2.On (b)(6) 2014: patient was evaluated for t12 and l1 compression fractures.Patient underwent thoracic spine ct without contrast due to back pain, snowmobile accident.Impression: questionable subtle superior endplate compression fracture involving the t12 vertebral body with loss of no greater than 5% of vertebral body height.At the t5-t6 level, there was a questionable central/right paracentral disc herniation which causes contact and flattening of the anterior margin of thecal sac.Patient also underwent lumbar spine ct without contrast impression: acute superior endplate compression fracture involving the l1 vertebral body.Loss of approx.5-10% of vertebral body height.Postoperative changes extending from l4 to s1 with grade 1 anterior spondylolisthesis of l5 on s1 as seen previously.No evidence of hardware loosening.Patient also underwent ct of chest, abdomen, and pelvis performed.On (b)(6) 2014: patient underwent x-ray of spine.Impression: there was re-demonstration of l1 superior endplate fracture with about 10% height loss.No definite bone retropulsion.No new or progressive lesions.Lumbosacral spine postoperative fusion changes are present.Normal disc spacing.

Event Description

It was reported that on (b)(6) 2011: the patient underwent x-ray of lumbar spine.Findings: seven intra-operative views of the lumbar spine demonstrated posterior rod and screw fixation of l4 to the sacrum.Inter-body spacers were present.

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.

Event Description

It was reported that on (b)(6) 2016, patient presented for evaluation after a motorcycle accident.Patient underwent ct of head: no evidence for acute intracranial hemorrhage, mass effect or acute ischemic event; soft tissue swelling and small laceration overlying frontal bones.Patient underwent ct of cervical spine: right sided c3 and c4 transverse process fractures with involvement of the vertebral foramina.Central canal and neural foramina are patent at all levels.

• 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: 5595430
• MDR Text Key: 43274932
• Report Number: 1030489-2016-01151
• 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,Followup,Followup
• Report Date: 09/16/2016

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 Catalogue Number: 7510200
• Device Lot Number: M110905AAQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/25/2016
• Initial Date FDA Received: 04/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 09/16/2016
• Supplement Dates FDA Received: 06/21/2016; 09/05/2016; 10/12/2016; 09/21/2017
• 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): Other
• Patient Weight: 106