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

Catalog Number 7510100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Pneumonia (2011); Renal Failure (2041); Weakness (2145); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4): neither device nor applicable imaging studies returned to manufacturer for evaluation.

Event Description

It was reported that on (b)(6) 2012 the patient presented with severe back pain and right posterior leg pain.The patient states that he has been having some urinary urgency for six months to a year.As per medical records, the patient has decreased rom and abnormal gait.X-rays: lumbar.Shows degenerative disc disease moderate at l5 and s1 and disc space collapse.Mri: lumbar.Shows disc bulge right moderate at l5 and s1 with good height to disc at l4-5 mild degenerative findings at the l4-5 disc, most severe at l5-s1.Assessment: l5-s1 spondylosis, ddd, r l5 radiculopathy.(b)(6) well controlled.On (b)(6) 2012 the patient presented the following pre-op diagnosis: degenerative lumbar disk disease, l5-s1, with lumbar spinal stenosis and spondylosis, as well as back pain and radicular pain.The patient underwent the following procedure: anterior surgical approach for extra-peritoneal exposure of l5-s1.Complete diskectomy, l5-s1.Complete decompression of the spinal canal, with decompression of the nerve roots bilaterally, as well as the central canal, l5-s1.Anterior spinal fusion, l5-s1.Placement of a machined structural allograft bone type of cage for anterior spinal fusion, l5-s1.Placement of a single blocking screw, with a washer to block the cage in place.Use of rh-bmp2/acs and allograft bone powder for anterior spinal fusion, l5-s1.Fluoroscopy.Neuromonitoring.Posterior spinal fusion, l5-s1.Instrumentation, l5-s1, using pedicle screw system, legacy.Use of stealth intraoperative computer-assisted surgical navigation and o-arm.As per op notes, the anterior surgical approach was performed.Once the l5-s1 level was exposed, x-rays were taken to verify the appropriate level and the diskectomy was performed to completely remove all the disk material.This allowed complete decompression of the spinal canal, nerve roots, and foramina bilaterally at the l5-s1 level.Under fluoroscopic guidance, a machined structural allograft bone type of cage was placed in the anterior interbody space.The center of this machined structural allograft cage contained rh-bmp2/acs, as well as allograft bone powder to help st imulate the bony fusion anteriorly.However, as it was slightly anterior to the ideal position, a blocking screw was placed.This was a single large fragment screw with a washer that was placed in order to create a blocking mechanism for the cage and to make sure that it stayed in place.The navigation probe was used to find the optimal pathway for making the incisions, and thus two longitudinal incisions were made approximately 3 cm in length over the l5-s1 levels in a trajectory parallel to the screw trajectories.After this, the awl and probe were brought into place.These were placed into the trajectory of the pedicle screws and tapped into place gently with a mallet, as well as using hand palpation to palpate down into the pedicles bilaterally.Thus, the pedicles were found.Once the pedicles were found, they were palpated and found to be quite solid at l5 and s1 bilaterally they were then placed using the navigated pedicle screwdrivers.Once the screws were in place, the facet at l5-s1 was gently denuded and a small amount of residual allograft bone powder was placed over the facet joints for posterior spinal fusion.The rods were placed into the pedicle screws and locked into place using the torque drivers.These rods and screws were locked nicely and were solidly in position.O-arm images post screw placement showed good alignment and position of the screws, and thus the procedure was deemed complete.There were no apparent complications.On (b)(6) 2012 the patient underwent xr o-arm.Impression: lntra-operative o-arm acquisition demonstrating appropriate position of anterior and posterior instrumentation at l5-s1 with interbody fusion graft located in the anterior aspect of the l5-s1 disc space.On (b)(6) 2012 the patient underwent x-rays ap and lateral views of the lumbar spine.Impressions: postoperative changes o1 posterior l5-s1 fusion without evidence of complication.On (b)(6) 2012 as per medical records, post-op day 1: patient complained of abdominal pain <(>&<)> back pain.Assessment: patient presented with decreased strength, flexion mobility and ability to perform ambulation and adls.No flatus or bowel movement.On (b)(6) 2012 the patient underwent x-rays of chest 2 views.Impressions: moderate left and small right lower lobe infiltrates are compatible with pneumonia/aspiration.On (b)(6) 2012 as per medical records, assessment post-op day 2: patient feeling very distended with crampy abdominal pain and back pain and no flatus or bowel movement.(b)(6) well controlled.Acute renal failure.Spinal ddd s/p c5-6 decompression.On (b)(6) 2012 as per medical records, assessment post-op day 3: (b)(6) well controlled.Acute renal failure post-op, stable.Possible aspiration pna.He exhibits distension.He exhibits edema.On (b)(6) 2012 as per medical records, assessment post-op day 4: he exhibits no distension and no edema.(b)(6) well controlled.Acute renal failure post-op, stable.Improved to 1.62 today.Possible aspiration pna.Leukocytosis l stable at 14.On (b)(6) 2012 the patient underwent x-rays ap and lateral lumbar spine for evaluation.Impression: appropriate appearance of l5-s1 anterior and posterior lumbar fusion with early incorporation across the interbody graft.On (b)(6) 2012 the patient presented with following pre-op diagnosis: left first toe lateral toe cyst, with pain.Ingrown toenail, left first toe, medial aspect of toe, with pain.The patient underwent the following procedure: excision, deep mass, lateral first great toe cyst with biopsy.Partial matricectomy of left first medial great toe spicule/toenail.The patient tolerated the surgical procedures well.No complications were noted.

• 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: 5052402
• MDR Text Key: 24981544
• Report Number: 1030489-2015-02186
• 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: 08/11/2015

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: 08/01/2012
• Device Catalogue Number: 7510100
• Device Lot Number: M111102AAN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2015
• Initial Date FDA Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/08/2011
• 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 Weight: 98