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 Dysphagia/ Odynophagia (1815); Inflammation (1932); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Respiratory Distress (2045); Weakness (2145); Osteolysis (2377); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that the patient underwent a posterior lumbar interbody fusion where rhbmp-2/acs was implanted with a metal cage.The patient's post-operative period was marked by pain.Following the surgery, the patient suffered from autonomic neuropathy, small fiber neuropathy, peripheral neuropathy, muscle atrophy and nerve damage, inflammatory reactions, radiculitis, retrograde ejaculation, sterility, osteolysis (bone resorption), displacement or migration of the spacer cage, pseudoarthrosis, dysphagia, difficulty breathing, and difficulty gripping and holding items, and chronic pain.The patient now suffers from bone overgrowth causing nerve compression, chronic pain and radiculitis, and emotional distress and mental anguish.

Manufacturer Narrative

Implant date: 2011.(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 on (b)(6) 2011, the patient underwent transforaminal lumbar interbody fusion and posterolateral fusion on the lumbar region of his spine from vertebrae l4 to l5.Reportedly, rhbmp-2/acs was used in this surgery.The rhbmp-2 collagen sponge was placed along with a cage, in the posterolateral gutter.Post-op, the patient experienced increasing low back pain, and left leg pain with tingling, weakness and numbness.Severe pain and symptoms ultimately compelled the patient to undergo a revision surgery on (b)(6) 2011.Following revision surgery, patient continued to experience low back pain.He also developed intermittent right groin pain, hip pain, and radiculopathy into his legs.The patient continues to experience chronic back pain, with pain radiating across his back and down his legs, constant stiffness in his back, and numbness and tingling in his right foot.He suffers from bowel and sexual issues, walks bent over, and cannot sit, stand or walk for extended periods of time.

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2011 patient was pre-operatively diagnosed with: l4-5 degenerative spondylolisthesis with facet ar throsis and segmental instability.L4-5 foraminal disk herniation with severe compression of the exiting l4 nerve root and traversing ls nerve root on the left.Failure of conservative measures and underwent the following procedures: minimally invasive transforaminal lumbar interbody fusion l4-5.Left-sided l4-5 transforaminal/transfacet decompression of the exiting l4 nerve root and the traversing ls nerve root.Segmental pedicle screw fixation into the pedicles of l4 and l5 bilaterally.Anterior interbody fusion with stryker unilif peek cage, 9 ml of bone, 6 of it autograft and 3 of it allograft, and 3/4 of a small bmp.Posterior right-sided facet fusion and posterior lateral fusion with the use of bmp, autograft and allograft bone.As per the op-notes, ¿we then made certain that our endplates were scored, but not dug into, and used our trials to find an appropriate sized implant for this level.We thought that a size 11 would be appropriate and therefore after packing 6 ml of autograft bone, then 3/4 of a small bmp then 3 more milliliters of allograft bone behind it, we placed our stryker unilif 11 mm peek lordotic cage with autograft bone inside of the graft window.We placed some duraseal over the top of the annulotomy so that the bmp would not leach posteriorly and give a bmp radiculitis.We then double checked to make sure that the traversing l5 nerve root was free and the exiting l4 nerve root was free.They were both well decompressed.We therefore placed our screws after re-palpating the cannulated pedicles.We then turned our attention to the patient's right side where another wiltse approach was performed.We did place a combination of autograft and allograft bone and 1/4 of a small bmp in the posterolateral gutter on that right side.Small connectors and a 35 mm rod was used to connect our screws after they were placed into the pedicles of l4 and l5 on the right side.Fluoroscopic x-ray was used both pa and lateral when we were finished to make certain that we liked our screw placement, and we did.¿.

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3672356
• MDR Text Key: 4242293
• Report Number: 1030489-2014-00689
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2014
• Device Catalogue Number: 7510200
• Device Lot Number: M111057AAP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2011
• 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 Age: 58 YR