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 Insufficient Information (3190)

Patient Problems Muscle Weakness (1967); Neuropathy (1983); Burning Sensation (2146); Tingling (2171); Stenosis (2263)

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)2011, patient presented for office visit with complaints of back pain down his left leg to his left foot.On (b)(6) 2011, patient presented with following pre-operative diagnosis: lumbar spondylosis, stenosis, and back and leg pain bilaterally at l4-5 and l5-s1.Procedure performed: l4-s and ls-s1 bilateral transfacet, extra foraminal diskectomy, l4-5 and ls-s1 right-sided trans facet lumbar interbody fusion, placement of a 12 mm high peek spacer on the right at l4-5 and 10 mm high peek spacer on the right at l5-s1, augmentation of the peek spacer with rhbmp-2/acs allograft, lateral transverse process fusion at l4, l5, and s1 bilaterally, using local autograft, segmental stabilization with pedicle screws and rods at l4, l5, and s1 bilaterally, placement of an epidural catheter percutaneously, for postoperative pain management.Per-op notes: an 14 and l5 laminectomy and l4-5 and l5-s1 facetectomy was carried out bilaterally.The s1 nerve root was also decompressed along its lateral recess, down to the next interspace, and once the foraminotomy had been completed, a large blunt hook could easily be passed out along the nerve root without any further impediment.The l4-5 and l5-s1 disk spaces were confirmed radiologically and entered through a trans facet lumbar interbody approach bilaterally.The l4 and l5 nerve roots were decompressed by removal of the lateral disk protrusions at l4-5 and l5-s1.The disk spaces were entered and emptied of as much disk material that could safely be removed.The pedicle screws were then placed in the pedicles at l4, l5, and s1 bilaterally.Each pedicle screw was placed under fluoroscopy.Each pedicle screw was tapped and sounded prior to the placement of the pedicle screw to ensure the pedicle screw was inside the pedicle.The l5-s1 disk space was then dilated to 10 mm and curetted extensively through a right-sided trans facet lumbar interbody approach.A 10 mm trial was placed in the disk space on the right through a trans facet lumbar interbody approach, and this was found to be the appropriate size.The appropriate-sized peek spacer was then selected and augmented with rhbmp-2/acs allograft.The peek spacer was then tapped into position.Once it was in good position, as monitored under fluoroscopy, the introducer was removed.A 12 mm trial was introduced into the right side through a trans facet lumbar interbody approach and found to be the appropriate.The appropriate sized peek spacer was selected and augmented with rhbmp-2/acs allograft.The peek spacer was tapped into position through a right-sided, trans facet lumbar interbody approach.Once it was in good position, as monitored under fluoroscopy, the introducer was removed.On (b)(6) 2011, patient discharged with following diagnosis: lumbar spondylosis and stenosis.On (b)(6) 2011, patient presented for visit with diagnosis of back pain.On (b)(6) 2011, patient presented for office visit with complaint of right leg numbness from the knee up.Also complaint of burning numbness and tingling across the right hip and down the leg to the ankle.On (b)(6) 2011, patient presented with chief complaint of pain.On (b)(6) 2011, patient presented for office visit.On (b)(6) 2011, patient presented with chief complaint of pain.On (b)(6) 2011, patient presented for visit with diagnosis of back pain.Still complains of intermittent right leg pain, also complaining of left heel pain.On (b)(6) 2011, patient presented with chief complaint of pain.He has constant back and right leg pain, and both feet and legs are burning.He has severe pain in his tail bone.On (b)(6) 2011, patient underwent lumbar spine mri with and without contrast.Impression: limited study due to prominent susceptibility artifact at the l4 through s1 levels secondary to posterior spinal fixation hardware.Postsurgical changes as described.Questionable moderate foraminal stenosis on the right at the l5-s1 level.Central canal widely patent.Small annular disk bulge l3-l4 with moderate bilateral foraminal stenosis, multifactorial in etiology.On (b)(6) 2011, patient presented with complaint of low back pain.Review of musculoskeletal system: not present ¿joint pain.Review of neurological system: not present- decreased memory.On (b)(6) 2011, patient presented for visit.Impressions of emg and ncv: i.Mila right sural sensory axonopathy which is most likely insignificant.The only abnormalities noted on needle (emg) exam is diffuse bilateral denervation to the lumbar paraspinal muscles.There was no peripheral myotomal abnormalities thus a lumbar radiculopathy cannot be diagnosed, these lumbar paraspinals abnormalities can be seen in postop lumbar surgical patients indefinitely.This can be due to irritation of the posterior primary rami innervated lumbar paraspinal muscles.3.No electrophysiological evidence of other entrapment/peripheral neuropathies or plexopathy.On (b)(6) 2011, patient presented with complaint of low back pain.Review of musculoskeletal system: not present ¿joint pain.Review of neurological system: not present- decreased memory.On (b)(6) 2012, patient presented with following diagnosis: lumbar radiculopathy and lumbar post laminectomy syndrome.On (b)(6) 2012, patient presented with complaint of low back pain.Review of musculoskeletal system: present- back pain, muscle cramps (feet bilaterally) and muscle weakness (bilateral legs).Review of neurological system: present ¿ numbness (right leg).Review of the lumbar mri show; evidence of fusion al l4-5 and l5-s1.There was moderate bilateral foraminal compromise at l5-s1.His pain seems to follow the l5 distribution with the right being much worse than the left.On (b)(6) 2012, patient presented with diagnosis of lumbar radiculopathy and lumbar post laminectomy syndrome.Procedure: bilateral l5 selective nerve root blockade.On (b)(6) 2012, patient presented with complaint of low back pain.Review of musculoskeletal system: present- back pain, muscle cramps (feet bilaterally) and muscle weakness (bilateral legs).Review of neurological system: present ¿ numbness (right leg).

• 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: 5177840
• MDR Text Key: 29253931
• Report Number: 1030489-2015-02796
• 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: 09/28/2015

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: 11/01/2013
• Device Catalogue Number: 7510200
• Device Lot Number: M111057AAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2015
• Initial Date FDA Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/19/2011
• 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