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 Incontinence (1928); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Vomiting (2144); Weakness (2145); Stenosis (2263); Injury (2348); Numbness (2415); Neck Pain (2433)

Event Type  Injury  

Event Description

It was reported that the patient underwent a spinal fusion surgery on the lumbar region of her spine from l5-s1 using rhbmp-2/acs.Reportedly, the patient's post operative period has been marked by chronic lower back pain and neck pain.The patient continues developed chronic lower back pain and numbness that radiates into her lower extremities.The lower extremity strength has diminished to the point she has difficulty ambulating.

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) 2013, the patient presented for follow up of general health.Pain in back was little better.(b)(6) 2013, the patient presented with chief complaint of chronic pain.(b)(6) 2013 the patient presented for follow up of back pain.(b)(6) 2013 the patient presented for follow up on back pain with med refills.(b)(6) 2013, the patient presented for follow up on back pain, med refills.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on : (b)(6) 2005, the patient underwent mri.The study revealed herniated disc presented at l5-s1.On (b)(6) 2005 the patient presented for an office visit due to right posterior sciatica.Impression:l5-s1 herniated nucleus pulposus on the right with right s1 radiculopathy.On (b)(6) 2006/(b)(6) 2015 the patient underwent diagnostic s1 transforaminal epidural steroid injection.On (b)(6) 2006 the patient presented for an office visit due to posterior right posterior sciatica.Diagnosis 1: right posterior sciatica; diagnosis 2: tobacco abuse.On (b)(6) 2006 the patient presented for an office visit due to back pain.Patient described pain radiating into the right extremity and down to the foot.On (b)(6) 2006, the patient presented with severe right posterior sciatica and underwent her medical record reviews and physical examinations.On (b)(6) 2006, the patient presented for various path/lab screenings: basic metabolic panel , cbc platelet , hematology , path non screen , chest xrays , erg/ecg.On (b)(6) 2006 , the patient presented with preoperative diagnosis for discogenic back pain at l5-s1 and s1 radiculopathy on the right.She underwent following op procedure : posterior spinal fusion, l5-s1 , with decompression of the right s1 and l5 nerve root.Facetectomy on the right and transforaminal interbody fusion with instrumentation and local bone graft.Patient's sample was taken for pathologic evaluation.Per op notes , the cartilaginous endplates were removed and good bleeding bone was obtained underneath.It was then sized and local bone was then impacted into the disk space.One half of a large rh-bmp2/acs packet was then placed with the disk space and the bone interbody spacer was then impacted into the interspace.Screws were then placed on the right in a similar fashion.The temporary rod was then moved and all screws were tested and found to have good signal.The rods were then placed and the caps placed and a small amount of compression placed across the posterior aspect of the fusion.Patient was discharged on (b)(6) jul 2006.On (b)(6) 2006 the patient presented for f/u her l5-s1 decompression with tlif and posterior instrumented fusion.She underwent x ray evaluation.On (b)(6) 20006 , the patient presented for f/u visit.Her pain condition has improved.She also underwent xray of her lumbar spine.On (b)(6) 2009, the patient was here due to sore throat , ear ache , cough , congestion.Assess- acute sinusitisment (b)(6) 2010, the patient was advised for mri cervical spine.On (b)(6) 2010, the patient presented for f/u of his back pain and physical and radiological evaluation.On (b)(6), per note , patient presented for office visit and underwent radiological examination.On (b)(6) 2011, the patient presented with neck and back pain and underwent his medical review , past history and physical examination and x-rays.Impression : tobacco abuse ; status post l5-s1 fusion ; chronic progressive low back pain ; chronic neck pain.On (b)(6) 2011, the patient presented for physical examination.On (b)(6) 2009 ; (b)(6) 2011; (b)(6) 2012, the patient presented for review on his back and neck pain condition and evaluation along with medicine refill.Patient complaint of join pain , stiffness and muscle spasm.Patient underwent radiological assessment on few of the occasions.Assessment : chronic back pain ; post laminectomy syndrome ; lumbago ; cervicalgia ; htn ; tachycardia; cardiology evaluation (b)(6) 2013; (b)(6) 2014; (b)(6) 2015 , the patient presented with low back pain ,spasm of muscle during his monthly checkup and medicine refill.Since the rh-bmp2/acs surgery, the patient has been suffering from severe back pain all the way up the spine, radiating down both legs and pain in feet; the pain is more severe and more frequent than before the infuse surgery; acid reflux; nerve injury; bowel incontinence; bladder incontinence; localized edema; rash on back; mental anguish; depression.The symptoms also included: rash on back; numbness from the waist down to both legs; weakness in legs and feet.The patient had pain when lifting heavy objects and some pain when bending over.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on, (b)(6) 2005, the patient underwent mri.The study revealed herniated disc presented at l5-s1.Impression: old compression fracture of the body of l1.Herniated disc at the level of l4-5 involving the right lateral recess more than the left side.Narrowing of the intervertebral neural foramen is noted at that same level.The conus medullaris is normal.On (b)(6) 2005, patient presented for office visit due to low back pain.Patient underwent x-ray of lumbar spine which showed some narrowing in l5 disc space and old minor healed compression fracture of l1 vertebra.On (b)(6) 2006: the patient presented for follow up.On (b)(6) 2006 : x-ray and mri showed old thoracolumbar compression fracture, degenerative disc disease at l5-s1 and right lateral recess stenosis.On (b)(6) 2006, patient underwent venous doppler ultrasound of right lower extremity.Impression: no evidence of deep vein thrombosis is identified in the right lower extremity at this time.On (b)(6) 2006, patient presented with severe right posterior sciatica.Mro from (b)(6) 2005 showed derniated disc at l5-s1 that was slightly asymmetric and lateralizing to right.On (b)(6) 2006, patient underwent x-ray of chest.Impression: lungs are somewhat hyperinflated, consistent with chronic obstructive pulmonary disease.No evidence of congestive failure, infiltrate, or effusion.Heart size id within normal limits.On (b)(6) 2006, patient underwent x-rays of lumbar spine.Impression: assuming there are five lumbar type vertebral bodies, there are bi lateral pedicle screws from posterior fusion at l5-s1.On (b)(6) 2006, the patient presented for follow-up on l5-s1 decompression with tlif and posterior instrumented fusion.Patient reported nausea vomiting after flare up of back pain.On (b)(6) 2010, the patient was underwent mri cervical spine without contrast.Impression: there is mild cervical spondylosis, primarily at c3-4.At this level, there is borderline spinal stenosis, but it is doubtful that there is actual nerve root compression.Clinical correlation is suggested in this regard; elsewhere, it does not appear that there is significant cervical spondylosis.No definite evidence of nerve root compression is seen.But is does appear that there is moderate uncinated joint lipping at c4-5 with no sign of spinal stenosis.Even here the findings do not arouse suspicion of nerve root compression; no chiari malformation is identified and there is no apparent tumor, syrinx or myelopathy of the cervical spinal cord or visualized portion of the brain stem; no fracture or luxation of the osseous spinal column is identified.It does appear that there are significant osteophytes associated with the diseased c3-4 disc.On (b)(6) 2010, patient presented for follow-up on neck and low back pain.Patient underwent x-ray of lumbar spine which showed intact hardware without subluxation or listhesis.No evidence of degenerative changes at l4-5 level.On (b)(6) 2011, patient presented for follow-up on neck and low back pain.Impression: recent flare up of low back and neck pain, suspected predominantly myofascial overlying multilevel degenerative disc disease; tobacco abuse; status post l5-s1 fusion.On (b)(6) 2011, patient presented for follow-up on neck and low back pain.Impression: chronic low back pain and neck pain, suspected predominantly myofascial overlying multilevel degenerative disc disease; tobacco abuse; status post l5-s1 fusion.On (b)(6) 2012, patient presented with complaint of persistent low back pain.Patient underwent x-rays of lumbosacral spine which showed diffuse levels and posterior hardware to be intact without evidence of loosening or failure.The adjacent disc level (l4-5) showed no significant change compared to her previous x-rays a couple of years ago.

• 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: 3596859
• MDR Text Key: 17386910
• Report Number: 1030489-2014-00263
• 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: 01/25/2016

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 Expiration Date: 12/30/2008
• Device Catalogue Number: 7510800
• Device Lot Number: M11500BAAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/02/2014
• Initial Date FDA Received: 01/29/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/14/2015; 02/15/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/28/2006
• 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 Age: 00039 YR
• Patient Weight: 54