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 Dysphagia/ Odynophagia (1815); Dyspnea (1816); Neuropathy (1983); Pain (1994); Tingling (2171); Numbness (2415); Ambulation Difficulties (2544)

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.

Event Description

It was reported that on (b)(6) 2014, patient underwent anterior cervical fusion surgery, posterior lumbar interbody fusion and transforaminal lumbar interbody fusion surgery.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.Reportedly, "patient's post-operative periods were marked by a period of improvement, followed by increasingly severe mid and lower back pain, radiculopathy, and difficulty breathing, speaking and swallowing.Severe pain compelled patient to undergo implantation of a spinal cord stimulator."allegedly," patient continues to experience difficulty in breathing, speaking and swallowing, constant mid and lower back pain, with pain radiating down his left side, and numbness and tingling in his left leg.He had difficulty sitting, standing and walking.".

Manufacturer Narrative

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) 2014, the patient was pre-operatively diagnosed with lumbar discogenic pain syndrome and underwent the following procedures: l3-l4 discectomy and posterior interbody lumbar fusion with 10 x 26 cage, bone matrix, autograft and arteriocyte.Arthrodesis l4-l5 transforaminal discectomy and fusion (tlif) with a 10 x 26 cage, bone matrix autograft, arteriocyte and rhbmp-2.Left l4-l5 transforaminal discectomy and fusion with a 10 x26 cage, bone matrix, rhbmp-2, arteriocyte and autograft segmental fusion l3-s1 bilaterally using instrumentation system physician-directed fluoroscopy, less than l hour.Lntraoperative monitoring, ssep, emg.Microdissection.As per op-notes, ¿ the skin was shaved, cleaned with alcohol, prepped with chloraprep.A #10 blade knife was used to open up the left side of the incision.Tubular retractors placed initially over the l5-s1, then the l4-l5 and then the l3-l4 in order.The superior facet was taken down.Discectomy at each level was performed.Bone matrix, rhbmp-2, and then the peek cage placed at each level across the midline in the disc space.¿.

• 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: 6019961
• MDR Text Key: 57053133
• Report Number: 1030489-2016-02851
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2017

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: 09/19/2016
• Initial Date FDA Received: 10/12/2016
• Supplement Dates Manufacturer Received: 08/14/2017; 08/14/2017
• Supplement Dates FDA Received: 09/04/2017; 09/06/2017
• 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