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

Catalog Number 7510600

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

Patient Problems Ossification (1428); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Urinary Tract Infection (2120); Tingling (2171); Stenosis (2263); Sore Throat (2396); Numbness (2415); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.

Event Description

It was reported that on (b)(6) 2004.Pre-op diagnosis: l5-s1 disc herniation.The patient underwent l5-s1 laminectomy and discectomy.No complications reported.On (b)(6) 2004: patient presented with severe low back pain with numbness into the buttocks and down the leg to the toes.Patient reported that approximately three to four weeks ago patient was jumping on a trampoline and several days later patient developed extreme low back pain.Imaging studies, including mri, indicated a broad based herniation to the left at the l5-s1 with pressure in the nerve roots on the left.Assessment: l5-s1 disc herniation.On (b)(6) 2006: patient underwent lumbar spine mri with and without contrast.Impression: there is a recurrent 2mm diffuse nonenhancing annular disc bulge at the l5-s1 level.It does not significantly affect the thecal sac or the s1 nerve roots.There is an enhancing focal area of scarring identified just posterior to the annular disc bulge at the l5-s1 level which just minimally abuts the ventral thecal sac and is abutting the left s1 nerve root within the left l5-s1 lateral recess.Mild disc space desiccation and endplate degenerative modic changes.No central/lateral recess stenosis or neural foraminal narrowing.A 2 mm annular disc bulge with a posterior annular tear and mild disc space desiccation just abuts the ventral thecal sac at the l4-5 level without significant focal disc protrusion, central/lateral recess stenosis, or any neural foraminal narrowing.Not previously mentioned is a 1.1 cm hemangioma within the l2 vertebral body.Otherwise, unremarkable mri of the lumbar spine with and without iv contrast.On (b)(6) 2006: patient presented with following pre-op diagnosis: post-lumbar laminectomy syndrome with recurrent disc herniation at l5-s1 level.Patient underwent following procedures: therapeutic left l5 selective nerve root block and epidural steroid injection.Therapeutic left s1 selective nerve root block and epidural steroid injection.Left l5 selective neurogram.Left s1 selective neurogram.Intraoperative fluoroscopy.No complications reported.On (b)(6) 2006: patient presented for follow up with surgical pain.Pre-operative pain had improved.Per doctor, x-ray looked good.On (b)(6) 2006 the patient presented with ddd, spondylolisthesis and lumbar stenosis.Patient underwent a l5-s1 decompression and posterior fusion using pedicle screw instrumentation with rhbmp-2/acs and intraoperative x-rays.Per the op notes, once the decompression was complete, the disc space was entered and the disc space cleaned out with curettes and rasps and the endplates decorticated with 11-mm tapered hollywood interbody fusion device filled with rhbmp-2/acs and allograft was placed in the disc space with good fit.No patient complications were noted.On (b)(6) 2006: the patient underwent lumbar spine x-rays.Impression: intact posterior fusion at the l5 and s1 levels.The patient was discharged home.On (b)(6) 2006 the patient presented with back pain and left leg numbness and underwent a lumbar spine mri which demonstrated no acute fractures or spondylolisthesis within the lumbar spine.The patient was status post posterior lumbar fusion at the l5 and s1 levels as well as interbody fusion at the l5-s 1 levels.The hardware and interbody fusion showed significant interval change in position or alignment in comparison to previous x-rays.A likely intra-osseous geode was seen within the left lateral aspect of the l5 vertebral body measuring up to 1.8 cm.The conus was located at the l1 vertebral body level.There was no abnormal signal originating from the spinal cord.There was a broad based posterior disc bulge at the l4-l5 level resulting in moderate bilateral neural bilateral foraminal stenosis, left greater than right.On (b)(6) 2006: the patient presented for follow up with new mri.The mri showed disk herniation with annular tearing and degeneration at l4-5 above the previous surgery.It looks like it has gotten worse since before.Doctor states he believes her fall probably did it.On (b)(6) 2004.Pre-op diagnosis: l5-s1 disc herniation.The patient underwent l5-s1 laminectomy and discectomy.No complications reported.On (b)(6) 2004: patient presented with severe low back pain with numbness into the buttocks and down the leg to the toes.Patient reported that approximately three to four weeks ago patient was jumping on a trampoline and several days later patient developed extreme low back pain.Imaging studies, including mri, indicated a broad based herniation to the left at the l5-s1 with pressure in the nerve roots on the left.Assessment: l5-s1 disc herniation.On (b)(6) 2004: patient underwent mri of the brain with and without contrast due to involuntary movement.Conclusion: unremarkable high field cranial mri with and without contrast.On (b)(6) 2006: patient underwent lumbar spine mri with and without contrast.Impression: there is a recurrent 2mm diffuse nonenhancing annular disc bulge at the l5-s1 level.It does not significantly affect the thecal sac or the s1 nerve roots.There is an enhancing focal area of scarring identified just posterior to the annular disc bulge at the l5-s1 level which just minimally abuts the ventral thecal sac and is abutting the left s1 nerve root within the left l5-s1 lateral recess.Mild disc space desiccation and endplate degenerative modic changes.No central/lateral recess stenosis or neural foraminal narrowing.A 2 mm annular disc bulge with a posterior annular tear and mild disc space desiccation just abuts the ventral thecal sac at the l4-5 level without significant focal disc protrusion, central/lateral recess stenosis, or any neural foraminal narrowing.Not previously mentioned is a 1.1 cm hemangioma within the l2 vertebral body.Otherwise, unremarkable mri of the lumbar spine with and without iv contrast.On (b)(6) 2006: patient presented with following pre-op diagnosis: post-lumbar laminectomy syndrome with recurrent disc herniation at l5-s1 level.Patient underwent following procedures: therapeutic left l5 selective nerve root block and epidural steroid injection.Therapeutic left s1 selective nerve root block and epidural steroid injection.Left l5 selective neurogram.Left s1 selective neurogram.Intraoperative fluoroscopy.No complications reported.On (b)(6) 2006 pre-op diagnosis: l5-s1 recurrent disc herniation, degeneration, and retrolisthesis.Procedures: l5-s1 laminectomy and discectomy and posterior spinal fusion with allograft rh-bmp2/acs, pedicle screw instrumentation, interbody fusion device and tapered cage.On (b)(6) 2006 intra-operative x-rays were taken and confirmed posterior fusion of the lumbar spine at the l5 and s1 levels on (b)(6) 2006: patient presented for follow up with surgical pain.Pre-operative pain had improved.Per doctor, x-ray looked good.The patient sustained unspecified injuries.

• 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: 5064238
• MDR Text Key: 25282608
• Report Number: 1030489-2015-02260
• 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
• Report Date: 08/14/2015

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: 7510600
• Device Lot Number: M115006AAG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/04/2006
• 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: 68