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

Catalog Number 7510800

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Arthritis (1723); Headache (1880); Pain (1994); Ulcer (2274)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.

Event Description

It was reported that (b)(6) 2005: patient was admitted to the hospital due to chronic pain.Patient was presented with pelvic pain as pre-op diagnosis and underwent laparoscopic assisted vaginal hysterectomy.Patient was presented with following post-op diagnosis: extensive pelvic adhesions and possibility of adenomyosis.On (b)(6) 2006: patient underwent the following pre-p diagnosis: spondylolisthesis with stenosis at l5-s1 and underwent posterior inter body fusion l5-s1 with posterolateral instrumented fusion with instrumentation with bilateral laminectomy and foraminotomy of l5- s1.Per op-notes: the s1 nerve root on the right side was reflected medially and hemostasis was obtained with bipolar electrocautery.A discectomy was then performed using a #15 scalpel followed by pituitary rongeurs, curettes and shavers.After a complete discectomy had been performed, the endplates were decorticated with an osteotome.The disc space was irrigated with sterile saline.The disc was packed with local bone graft following by peek cage packed with rh-bmp2/acs sponge.This was inserted using an impactor and mallet.It was felt to have good position and stability.Ap and lateral c-arm films were taken which verified good position of the cage and screws.There was good reduction of the spondylolisthesis.The incision was then irrigated with sterile saline followed by antibiotic irrigation.The transverse processes of l5 and s1 were decorticated using rongeurs and an osteotome.Local bone graft was morselized and impacted along the transverse processes from l5 to s1 bilaterally.Rh-bmp2/acs sponges were packed with bone graft and placed from l5 to 51 bilaterally.A good fusion bed was created bilaterally.Titanium rods were then placed over the screws using connectors.These were tightened down using set screws.After final tightening, it was felt there was good stability at the l5 to s1 bilaterally.An epidural catheter was placed underneath the l4 lamina, which was passed through into the epidural space.The incision was closed using a running suture in the lumbosacral fascias followed by running suture in the subcutaneous tissue over a hemovac drain and a 3-0 monocryl suture was used for the skin.A sterile dressing was applied.The patient tolerated the procedure wall.All sponge and needle counts were correct.The patient was taken to the recovery room in good condition.No patient complications.Patient was discharged on (b)(6) 2007.On (b)(6) 2012: patient presented with an office visit due to experiencing a fall.Pain in leg and lower back was getting worse.On (b)(6) 2012: patient presented with an mri due to hnp.Impressions: previous bilateral laminectomy at l5-s1 disc space with minimal anterior subluxation of l4 over l5 with posterior interpedicular fusion.Satisfactory decompression of central spinal canal at this level.No evidence of a focal herniated disc pulposus.On (b)(6) 2012: patient presented with an mri of the lumbar spine due to low back pain and bilateral leg pain and numbness.Impressions: mri demonstrates postsurgical changes at l5- s1.No significant disc degenerative changes, herniations or stenosis above the surgery.There was some facet hypertrophy and bowing due to bilateral recess stenosis at l5-s1.On (b)(6) 2012: patient presented for an office visit with severe headache and worsening low back pain, bilateral leg pain and numbness.Impressions: spinal stenosis l5-s1 status post fusion.On (b)(6) 2012: patient underwent ct scan of the lumbar spine without contrast due to pain.On (b)(6) 2012: patient presented with following pre-op diagnosis: spinal stenosis, l4-l5 and underwent laminotomy, foraminotomy, l4-5 with hardware removal, exploration and fusion, l5-s1 procedures.No patient complications were reported.On (b)(6) 2012: patient presented with an office visit post l5-s1 hardware removal, laminectomy and revision fusion.Impressions: spinal stenosis status post decompression and fusion.Patient also underwent an x-ray of the ap lateral lumbar spine due to lower back pain.Patient's x-rays demonstrate good position of the l5-s1 level.There was interval hardware removal.There was abundant posterolateral bone graft.On (b)(6) 2012: patient visited for an office visit post hardware removal and revision fusion.Impressions: spinal stenosis, pseudoarthritis status post decompression and fusion.Patient also underwent an x-ray of ap lateral lumbar spine.Patient's x-rays demonstrate good position of the lumbar spine.There was further consolidation of the bone graft.There was good alignment.On (b)(6) 2012: patient presented for an office visit due to pain- stenosis.Patient also underwent x ray which revealed good position of the lumbar spine.There appeared a solid arthrodesis at l5-s1.Impression: herniated disc with spondylolisthesis status post decompression and fusion.On (b)(6) 2013: patient presented for a follow-up visit post lumbar fusion.Assessment: paint- lbp lumbago and pain- stenosis.Patient also underwent an x ray of the ap lateral lumbar spine.Impressions: pseudoarthrosis status post revision fusion.On (b)(6) 2013: patient presented with lumbago, stenosis and stomach ulcers post lumbar fusion.Assessment: lumbago and stenosis.Patient also underwent an x ray of ap lateral lumbar spine.Impression: herniated disc with stenosis status post decompression and fusion.

• 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: 5143721
• MDR Text Key: 28040273
• Report Number: 1030489-2015-02631
• 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: 10/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2009
• Device Catalogue Number: 7510800
• Device Lot Number: M110603AAC
• 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
• Date Device Manufactured: 11/21/2006
• 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): Other
• Patient Weight: 79