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

Catalog Number 7510600

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); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Type  Injury  

Event Description

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

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.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2006: the patient was pre-operatively diagnosed with: internal disc disruption and degenerative disc disease l5-s1; spinal stenosis l5-s1; low back pain and lower extremity radiculopathy and underwent the following procedures: radical wide extensive total and complete discectomy at the l5-s1 level with complete removal of disk; complete removal of cartilaginous end plates; bony end plate contouring and central canal decompression; anterior inter body fusion (arthrodesis) at the l5-s1 level; anterior segmental titanium instrumentation at the l5-s1 level using four-hole titanium plate and locking screw system; use of lt threaded titanium cage measuring 14 mm in height: 23 mm in length at the l5-s1 level on right; this functions as a biomechanical device for the intervertebral defect for the l5-s1 level on right; use of lt threaded titanium cage measuring 14 mm in height, 23 mm in length at the l5-s1 level on the left; this functions as a biomechanical device for the intervertebral defect for the l5-s1 level on left.As per op-notes, ¿a cage lt threaded titanium cage measuring 14 mm in height and 23 mm in length¿was placed at l5-s1 on the right¿the cage measuring 14 mm in height and 23 mm in length was placed at l5-s1 on left.We then used bone morphogenic protein soaked in collagenous sponges.This was placed within the cages as well as the interstices around the cage and our inter body fusion and arthrodesis at the l5-s1 level was completed.Fluoroscopy, ap, lateral, and oblique planes demonstrate acceptable position, alignment, instrumentation and construct placed.The patient tolerated the procedure well without intraoperative complication.¿.

Manufacturer Narrative

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

• 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: 3659392
• MDR Text Key: 4284968
• Report Number: 1030489-2014-00718
• 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
• Report Date: 06/14/2016

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
• Device Catalogue Number: 7510600
• Device Lot Number: M115004AAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/04/2014
• Initial Date FDA Received: 03/05/2014
• Supplement Dates Manufacturer Received: Not provided; 06/14/2016
• Supplement Dates FDA Received: 07/11/2016; 09/23/2017
• 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
• Patient Age: 36 YR