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 Problem Injury (2348)

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.If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2008: the patient presented for an mri of the lumbar spine with and without contrast scan.Impressions: right hemilaminectomy and discectomy with recurrent disc herniation in the right lateral recess at l5-s1.There is enhancement of the recurrent disc and scar formation in the right lateral recess and right epidural space.Intra and extraforaminal focal disc herniation at the l4-l5 level with likely neuritis of the exiting left nerve rootlet.Minimal transverse narrowing of the posterior thecal sac at l3-l4 due to facet hypertrophy.On (b)(6) 2017: patient presented for office visit with low back and right lower extremity pain.Review of systems: musculoskeletal systems: complains of blurring and photophobia.Patient underwent radiological imaging.Impressions: bilateral upper limbs.Lower back pain.Radiculopathy.On (b)(6) 2017: patient presented for office visit.Patient underwent ct scan of lumbar spine without contrast.Impression: facet changes with vacuum facet on right at l4-5 with some tissue in left lateral position suggesting broad based disc and or scar causing left neural foramina narrowing.On (b)(6) 2017: patient presented for office visit.Review of systems: musculoskeletal systems: complains of fatigue and back pain.Patient underwent radiological imaging.Impressions: bilateral upper limbs.Lower back pain.Radiculopathy.On (b)(6) 2017: the patient presented with the following pre-op diagnosis: lumbar degenerative disc disease, degenerative joint disease, stenosis, radiculopathy.Patient underwent following procedures: right l4-5 and l5-s1 transforaminal lumbar interbody fusion with far lateral transpedicular decompression of exciting and traversing nerve roots, pedicle screw instrumented fusion from l4 to s1, posterolateral fusion from l4 to s1.As per-op notes: ¿bony elements from l4 to s1 were decorticated and morselized with local autograft and allograft and placed down laterally as well as some bmp to perform posterolateral fusion from l4 to s1.¿ no intra-operative complications were reported.On (b)(6) 2018: patient presented for office visit.Review of systems: musculoskeletal systems: leg and back pain.On (b)(6) 2018: patient presented for office visit with complaint of right lateral thigh discomfort.Review of systems: musculoskeletal systems: complains of sciatica.Impression: radiculopathy.Disc degeneration.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported per patient¿s medical records that on: (b(6) 2016: patient underwent 4-5 views of cervical spine.Impression: normal cervical spine (b)(6) 2017: patient underwent ct scan of thoracic spine without intravenous contrast due to thoracic pain, radiculopathy.Impression: 1.Some mild disc space narrowing and spondylosis involving the thoracic spine.No gross protrusion, spinal stenosis or foraminal narrowing.2.2 mm right renal stone without hydronephrosis.(b)(6) 2017: patient presented with muscle weakness; decreased range of motion of trunk and back; chronic right-sided low back pain with right-sided sciatica; difficulty walking; impaired functional mobility, balance and endurance.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8058788
• MDR Text Key: 126922345
• Report Number: 1030489-2018-01465
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 11/12/2018
• Supplement Dates Manufacturer Received: 11/13/2018
• Supplement Dates FDA Received: 12/12/2018
• 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: 111