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

Catalog Number 7510800

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

Patient Problems Cramp(s) (2193); Stenosis (2263); Joint Swelling (2356); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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) 2007 patient presented with following pre-operative diagnosis: degenerative disc disease, stenosis, herniated nucleus pulposus, l4-5, l5-s1.Following operations performed: l4 through s1 posterolateral fusion with pedicle-screw instrumentation.L4-5, l5-s1 transforaminal lumbar interbody fusions using peek cage and bone morphogenic protein.Bilateral discectomies at l4-5 and l5-s1.Placement of cage, l4-5, l5-s1.Pedicle-screw instrumentation of l4 through s1, segmental.Per-op notes: surgeon removed the disc herniation that were tenting the exiting nerve roots and then removed the disc material from underneath them.Following this, they went ahead and entered the disc space in earnest with the instrumentations from the alphatec spine set to remove the disc from the disc material, scraped the endplates of cartilage with curets, and removed all of the disc material in its entirety.Surgeon did a trial for the appropriate-size peek cage and inserted it diagonally across the disc space.Once they had used a rasp and smoothed the endplates, they used a medium kit of bmp at each level.Surgeon placed the bmp, and then placed the cage behind it.Complications: one small dural tear, which was repaired.Radiological examination impression: portable fluoroscopy utilized for 11 second.Status post l4 through s1 pedicle screw fusion with diskectomies and posterior decompression.Review of musculoskeletal system: complains of back pain, muscle weakness, neck pain.Review of neurological system: complains of headaches, numbness, and weakness.Review of psychiatric: denies drug abuse, anxiety, depression, nervousness.Other implants used: novel sp acer (1) , polyaxial screw, locking nut, rod (2).On (b)(6) 2007 patient discharged.On (b)(6) 2007 patient presented with mild complaint of numbness in the left leg.X-rays demonstrate good position of the hardware, bone graft and screws.On (b)(6) 2007 patient presented for follow up visit.X-rays today demonstrate excellent position of hardware.Bone graft with some early bone formation in the interbody spaces.Impression: overall she was doing well.On (b)(6) 2007 patient presented with back pain.X-rays today demonstrate good position of the hardware, bone graft, and screws.Impression: overall she was doing well.Review of neurological examination: she was intact with good strength.On (b)(6) 2007 patient presented for follow up visit.On (b)(6) 2012 patient underwent x-ray- cervical spine 2/3v.Impression: c4-c7 anterior cervical discectomy and fusion with apparent bony fusion of the vertebral bodies.Alignment at c7-t1 was not well assessed.On (b)(6) 2012 patient presented with cervical spine pain, bilateral hand numbness sometimes at night and sometimes when she was driving.Review of neurological system: headache, paresthesia.Pain going down arm and leg.Review of musculoskeletal system: back pain, muscle weakness, myalgia, neck pain, arthritis, stiffness, night cramps, joint swelling, and history of fractures.On (b)(6) 2012 patient underwent mri- cervical spine w/o and w/c contrast.Impression: antenor metallic fusion of c4 through c7.Neural foraminal stenosis as described above.No 'ourrern' mri evidence of neurologically significant cervical central spinal stenosis.Impressions: facet degenerative change of the lower lumbar spine without central canal or neuroforaminal stenosis.Mild diffuse disc bulge at l1-l2 results in mild right lateral recess stenosis.X-ray impression: stable anterior cervical fusion from c4 through c7.X-ray- cervical spine 2/3v impression: c4--c7 anterior cervical discectomy and fusion with apparent bony fusion of the vertebral bodies.Alignment at c7-t1 was not well assessed.On (b)(6) 2012 patient presented for office visit.Patient had some enlarged facet joints just above the fusion at l3-l4 which could be causing some back pain.

• 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: 5078202
• MDR Text Key: 25881148
• Report Number: 1030489-2015-02362
• 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: 08/17/2015

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: 06/01/2009
• Device Catalogue Number: 7510800
• Device Lot Number: M110603AAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2015
• Initial Date FDA Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/21/2006
• 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: 113