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 Diarrhea (1811); Dysphagia/ Odynophagia (1815)

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 on (b)(6) 2009, patient underwent following procedure: 1.L5 gill laminectomy.2.L5-s1 posterior pedicle screw fixation and posterolateral fusion using bmp, osteacel plus, and autograft; for a pre-op diagnosis of l5-s1 non-union from prior alif.Per-op notes: patient had developed chronic back pain, bilateral leg pain and numbness.Skin incision was made over the tips of the spinous processes of l4, l5, and s1.Pedicle screw placement was initiated.The procedure far pedicle screw placement was the same at every level.Using a combination of anatomical landmarks and fluoroscopy, an appropriate entry point was established and a pilot hole was drilled.Next, an l5 gill laminectomy was performed and there was complete removal of bilateral l5 facets and lamina, and the l5-s1 neural foramina were completely opened and decompressed bilaterally.Decompression was confirmed by passing the footplate of a woodson instrument through the foramina and distally along the s1 nerve root tract bilaterally.Following this, the bone around the pedicle screws and transverse processes and iliac ala was denuded with high-speed electric drill, and then bmp soaked sponge as well as osteocel plus and autograft was placed into the posterolateral gutter, bridging between l5 and s1.Next, the 45-mm lordotic rods were placed on the screw heads.The locking caps were put into position, and the screws were locked to their specified torque.On the left-hand side while placing a cap, it was noticed that there was a partial medial breakout of the left s1 pedicle screw.This screw was removed, the hole was probed, and the distal portion of the hale was determined still to be intact.A 7 x 40-mm screw was then inserted into this same pedicle screw hole, and it was inserted through the inner cortex of the sacrum through to assure distance, to achieve bicortical purchase.No complications were reported during the procedure.On (b)(6) 2009, patient underwent cystoscopy with left ureteroscopy and stone extraction, retrograde pyelogram, stent placement; for a pre-op diagnosis of left ureteral calculus.On (b)(6) 2010, patient underwent colonoscopy for a pre-op diagnosis of crohn's disease and diarrhea and post-op diagnosis of no evidence of crohn's disease, normal colon, normal anastomosis, and normal ileum.On (b)(6) 2010, patient underwent upper endoscopy and biopsies, for a pre-op diagnosis of dysphagia and post-op diagnosis of barrett esophagus.

• 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: 5255734
• MDR Text Key: 32355089
• Report Number: 1030489-2015-03252
• 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
• Report Date: 11/02/2015

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 Expiration Date: 08/01/2011
• Device Catalogue Number: 7510200
• Device Lot Number: M110804AAJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/29/2009
• 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: 70