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 Dyspnea (1816); Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

It was reported that per medical records on (b)(6) 2003, patient reported back pain that radiates into buttocks bilaterally left greater than right, numbness in left lateral calf, and dorsum of foot since surgery.Mri showed mild degenerative changes with bulging at l4-5 and moderate at l5-s1.X-rays showed slight narrowing at l4-5 and l5-s1.Ap lateral flexion extension lateral ferguson and oblique views.Cages appear to be within the central portion of the disc spaces.Screws appear to be in satisfactory position on the ap and lateral view but with a more straight ahead appearance.There are lucencies around the s1 screws bilaterally.Ct scan showed satisfactory screw placement at l4 and on the right at l5.On the left the screw is more vertical and does enter anteriorly outside of the vertebral body margin minimally.At s1 the right s 1 screw appears to contact the s 1 nerve root, left sided screw is satisfactorily placed.The facets are not fused at l4-l5 or l5-s1 interbody fusion bone is minimal and is within the cage only, reconstructed views in both sagittal and coronal views fail to demonstrate any fusion within the vertebral bodies.There are reactive changes of sclerosis adjacent to the implants, int ertransverse fusion is not contiguous.Retained wires from an ebi stimulator are noted.It does not appear that there is any hardware loosening at this time.On (b)(6) 2003, patient underwent following procedure: left ttroperitonial exposure of lumbosacral spine with mobilization of great vessels, exploration of spinal fusion with removal of loosened cages and debridement of pseudoarthritis.Alif using allograft spacers and bmp, for a pre-op diagnosis of pseudoarthritis post instrumentation status plif, l4-5 and l5-s1.Per-op notes: at l5-s1 disc ectomy was performed.Annulus was opened and remaining disc material removed, exposing the cage; majority of motion was between implant and s1 endplate.Disc spacer was placed in the interspace.Cage was retrieved and complete discectomy was performed.In similar fashion exposure of implant at l4-5 was performed.Interbody fusion was performed using allograft iliac crest spacer which were fashioned to be 14 mm in height posteriorly and 20mm in height anteriorly at l5-s1 and 18mm in height anteriorly and 14 mm in height posteriorly at l4-5.Bmp was placed anteriorly and posteriorly to the implant.Satisfactory c-arm images were obtained.No complications were reported during the procedure.On (b)(6) 2003, patient presented for follow-up six weeks post fusion surgery.Patient reported mild back discomfort with activities.X-rays showed satisfactory graft position with lordosis.No hardware complications.On (b)(6) 2003, patient presented for follow-up.Patient reported low back discomfort.Ct scan of lumbar spine showed excellent arthrodesis at l4-5, the partial arthrodesis at l5-s1.There was evidence of perhaps screw loosening at l4 on the left seen on reformat #29, there may be some loosening also in the pedicle of l5.On (b)(6) 2003, patient presented for follow-up.Ct scan of lumbar spine showed excellent incorporation of the graft into both endplates at l4-5.At l5-s1, there remains incomplete fusion to the sacrum impression: solid interbody fusion at l4-5 and l5-s1, no ct evidence of pseudoarthrosis, mild-moderate spinal canal stenosis at l3-4.Mild-moderate bilateral neural foraminal narrowing at l3-4 and l4-5 is slightly worse on the left, especially at l4-5.4.No complication of the metallic hardware, transpedicle screws and vertical connecting struts are again identified bilaterally at l4, l5, and s1.On (b)(6) 2003, patient presented for follow-up six months post fusion surgery.X-rays showed solid arthrodesis at fusion site.On (b)(6) 2004, patient presented for follow-up.Patient reported thigh pain with cold weather.X-rays showed solid fusion at l4-5 and lucency around l5-s1 screws but no fusion.On (b)(6) 2006, patient underwent mri of thoracic spine.Impression: normal thoracic spine mri.Patient underwent mri of lumbar spine with/without contrast.Impression: interval postoperative changes with posterior fusion a l3- 4 through l5-s1.L3-4 mild acquired central stenosis.At most mild rive neuroforaminal stenosis but perineural fat of tbe l3 nerves is fairly well preserved regardless.No evidence for arachnoiditis, loculated collection or infection.On (b)(6) 2013, patient called to report that he had difficulty in breathing for past 3 years and had tracheostomy.

• 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: 5126710
• MDR Text Key: 27444535
• Report Number: 1030489-2015-02547
• 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: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• 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: 09/28/2015
• 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: 73