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 Hepatitis (1897); High Blood Pressure/ Hypertension (1908); Muscular Rigidity (1968); Nausea (1970); Neuropathy (1983); Pain (1994); Renal Failure (2041); Pressure Sores (2326); Arthralgia (2355); Depression (2361); Neck Pain (2433)

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) 2005 the patient presented with metatarsus primus varus with hallux valgus, left foot.The patient underwent the following procedure: osteotomy of first metatarsal, left foot.Osteotomy of proximal phalanx, left great toe.(b)(6) 2005 the patient was admitted with chief diagnosis of syncope.Ct study of brain without iv contrast was suggestive of mild cerebral atrophy, no acute intracranial pathology, no adverse compared to the prior ct study.Eeg report revealed abnormal secondary to generalized slowing of the background and generalized and bifrontal superimposed slowing consistent with mild to moderate generalized encephalopathy of non-specific etiology.(b)(6) 2005 the patient was discharged from hospital.(b)(6) 2007 the patient underwent mri scan of lumbar spine without contrast.Impression: extensive degenerative disc seen at l4-l6 and l3-l4 levels with bone marrow changes.There was edema seen in l3-l4 vertebra which was likely on degenerative basis.Given young age of patient and extensive edema in l3 and l4 follow up may be obtained in 3 months to determine stability.Diffuse disc bulge at the l3-l4 levels with left paracentral disc protrusion at l5-l6 level causing severe neutral foraminal encroachment as above.(b)(6) 2007 the patient presented with low back pain.The patient underwent bilateral decompressive laminotomies and posterior lumbar interbody fusion using a polar technique at l3-4 and l4-5 on the left and posterior lumbar interbody fusion with bilateral grafts at l5-s1.Per op notes: the surgeons dilated the disk space up using the end plate scrapers and were able to place without so much difficulty a 10 millimeter tall graft into the disk space and seated quite well.Unfortunately, in the course of this there was a small csf leak from the axilla of the left l4 nerve root as the thecal sac was retracted medially.This was easily controlled with a pledget of gelfcam and a cottonoid.The surgeons then turned their attention down to the l5-s1 interlaminar space and performed essentially the same procedure.They placed the bone graft into position and attempted to seat it in place; it hung up on the end plate and shattered.Pieces were retrieved.The bone graft which had the previous one was filled with bone morphogenic protein.This was retrieved.They adjusted the angle of approach and seated the bone graft rather better without really much difficulty.The patient's right side and performed essentially the same procedure with really essentially the same findings including the bone graft at l5-s1.This graft was retrieved as has been the other.The same problem was identified and the second graft seated well.Bone graft had been placed sufficiently obliquely that it had very dramatically crossed the midline and actually appeared to have dislocated so that it was sitting transversely across the mid portion of the disk space.Surgeon prepared some demineralized bone matrix and performed an aspirate of bone marrow from the previously cannulated right l4 pedicle and placed the bone graft into the disk space, further supporting the graft.The sane procedure was performed at l3-4 on the right side.The bone graft was again seen to be quite obliquely and was actually a polar type graft.They used additional bone graft combined with bone marrow aspirate and seated it into the disk space there as well.The grafts were all inspected and seated well.The following implants were used pedicle screw, rod, peek cages.(b)(6) 2007 the patient discharged from hospital.Discharge diagnosis: severe low back pain secondary to advanced degenerative spon dylolisthesis al l3-4 and l4-5 with severe facet degeneration at l5-s1 on the left.(b)(6) 2007 the patient presented for the follow up.Impression: status post bilateral decompressive laminotomies and posterior lumbar interbody fusion using the polar technique at l3-4 and l4-5 on the left and posterior lumbar interbody fusion with bilateral grafts at l5-s1 for low back pain secondary to advanced degenerative spondylolisthesis.He was doing well from his surgery but is still bothered by the pressure sores incurred during the lengthy procedure.(b)(6) 2007 the patient presented for the follow up of bilateral decompression and fusion.(b)(6) 2007 the patient presented for the follow up of bilateral decompression and fusion performed utilizing the minimally invasive approach from l3 to s1.Impression: status post extensive minimally invasive bilateral decompression and fusion from l3 to s1, inclusive.The patient is actually doing quite well from his surgery at this time.(b)(6) 2007 the patient presented for the follow up.Impression: status post extensive minimally invasive bilateral decompression and fusion from l3-s1, inclusive.The patient appears to be suffering more from a lumbar muscular strain at this time.15 nov 2007 the patient underwent ct scan of lumbar spine.Conclusion: slightly limited exam without contrast.No definite evidence of hardware failure or fractures.Please see above.Diffuse bony sclerosis involving the lower lumbar spine of uncertain etiology.Some irregularity of the endplates particularly at l3-l4, however, based on the preoperative studies, there was significant degenerative chance here and this all may be postoperative in nature, although clinical correlation was requested to exclude the small possibility of infection.(b)(6) 2007 the patient presented for an office visit due to back and lower extremity pain.The ct scan of the lumbar spine revealed the bone graft and pedicle screws to be in very good position with the single exception of the left l5 pedicle screw which is positioned just a little bit lateral of the pedicle, traversing the lateral mass and lateral margin of the pedicle but not apparently involving the nerve root or neuroforamen.The left s1 pedicle screw was a little closer than 1 might like to the neuroforamen but did not appear to have violated the medial wall of the pedicle.Diagnosis/impression: patient appeared to be suffering from persistent lumbar myofascial pain.(b)(6) 2008 the patient admitted to the hospital due to acute renal failure, abnormal movements.Assessment: acute renal failure secondary.Rhabdomyolysis, secondary to possible seizures or shaking or jerking movements from withdrawal of opiates.Since the patient is on kadian, which is morphine sulfate, she takes 80 milligrams twice a day for a long time.Dehydration due to nausea and vomiting.Diabetes mellitus.Hypertension, (b)(6).Metabolic acidosis from renal failure.(b)(6) 2008 the patient discharged with following diagnosis: acute renal failure, rhabdomyolysis, acute respiratory failure secondary to sleep apnea, diabetes, hypertension (b)(6) 2008 the patient admitted to the hospital.(b)(6) 2008 the patient discharged with following diagnosis.Respiratory failure secondary to sedation.Renal failure from rhabdomyolysis.(b)(6).Chronic pain.Hypertension.(b)(6) 2010 the patient presented for the follow up due to neck, left shoulder, low back and bilateral lower extremity pain, left more than right.Diagnostic impression: lumbar radiculitis.Status post lumbar fusion, 360.Diabetes.Blindness, left eye.Myofascial disease.Possible medication issues.(b)(6) 2010 the patient presented for the follow up.Impression: lumbar fusion.Diabetic neuropathy.Diabetes.Myofascial pain.Possible medication issues.(b)(6) 2010 the patient presented for the follow up in regards to complaints of low back and bilateral lower extremity pain.Assessment: lumbar postlaminectomy syndrome.Lumbar fusion l3 through s1.Diabetes with diabetic neuropathy.Myofascial pain.(b)(6) 2010 the patient present for an office visit due back pain, bilateral lower extremities and neck pain.Impression: lumbar fusion.Diabetic neuropathy.Diabetes.Myofascial pain.Possible medication issues (b)(6) 2011 the patient presented for the follow up in regards to complaints of multiple aches and arthralgias.Assessment: lumbar radiculopathy.Lumbar postlaminectomy syndrome.Diabetic neuropathy.Diabetes.Myofascial dysfunction.Osteoarthritis.(b)(6) 2011 the patient presented for the follow up in regards to back pain and lower extremity pain.Assessment: lumbar postlaminectomy syndrome.Lumbar radiculopathy.Diabetic neuropathy.Diabetes.Myofascial dysfunction.Osteoarthritis.Depression.(b)(6) 2011 the patient presented for follow up complaints of back pain and lower extremity pain.Assessment: lumbar post laminectomy syndrome.Lumbar radiculopathy.Diabetic neuropathy.Diabetes.Myofascial dysfunction.Osteoarthritis.Depression.History of thc use.

• 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: 5079789
• MDR Text Key: 25885718
• Report Number: 1030489-2015-02374
• 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

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2009
• Device Catalogue Number: 7510800
• Device Lot Number: M110606AAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2007
• 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: 142