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

Catalog Number 7510400

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

Patient Problems Neuropathy (1983); Pain (1994); Urinary Frequency (2275); Depression (2361); Loss of consciousness (2418)

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.

Event Description

It was reported that on (b)(6) 2011: the patient presented with low back pain and leg pain.The patient underwent x-ray.Impression: spondylolisthesisl5-s1, degenerated disc with high intensity zone l4-5 (b)(6) 2011: the patient presented with pre-operative diagnosis of painful lumbar disc disease, l4-5 and l5-s1, lumbar stenosis, post-lami syndrome and underwent: anterior lumbar interbody fusion, l4-5, anterior lumbar interbody fusion, l5-s1, insertion of biomechanical prosthetic device, l4-5, insertion of biomechanical prosthesis device l5-s1, posterior pedicle screw instrumentation, l4 to s1, bmp, neuromonitoring.Perop notes: after conforming the operative level of l4-5, a complete discectomy was performed using a scalpel, penosteal elevator, curettes and pituitary rongeurs.Segmental distraction was then carried out.An endplate rasp was passed through the segment to retrieve any residual cartilage.The appropriately sized titanium prosthesis was then selected and packed with bmp.It was carefully impacted into the interspaces and recessed.After completion of the discectomy and fusion at l4-5, attention was turned to l5-s1.An identical procedure was performed on l5-s1.During the course of procedure the guide wire taps and pedicle screw placement was done under fluoroscopic control.A rod was passed through pedicle screws of l4, l5 and s1 screws under fluoroscopic control.(b)(6) 2011: the patient underwent postop evaluation.Impression: no change in the appearance of the postop lumbar spine with fusion change from l4-s1.(b)(6) 2011: the patient was discharged.(b)(6) 2011: the patient presented one month post op.Impression: arthrodesis, l4 through s1, congenital spondylolisthesis, l5-s1, d egenerative disc l4-5.(b)(6) 2011: the patient presented with chief complaint back and leg pain.Impression: congenital spondylolisthesis, l5-s1, degenerative disc, l4-5, fusion, and l4 through s1.(b)(6) 2011: the patient presented with subjective complaint of three months, three days status post arthrodesis.L3 through the sacrum.Ros revealed: impression congenital spondylolisthesis,ls-51, degenerative disc, l4-5 arthrodesis l4 through the sacrum.The patient underwent x-ray of lumbar spine with flexion and extension.Impression: stable appearance at the l4 to s1 anterior and posterior lumbar fusion.(b)(6) 2011: the patient presented with the subjective complaint of four and a half months postop fusion.Ros revealed: positive for frequency of urination.(b)(6) 2011: the patient presented with subjective complaints of the patient was seen with an interpreter.The patient's language is from (b)(6).The patient underwent physical examination: psychological evaluation: the patient does appear somewhat depressed compared to last ps ychological energy which does appear different than when the patient is under medication for his depression.Impression: spondylolisthesis, ls-51, congenital., degenerative disc, l4-5, arthrodesis, l4 through the sacrum, degenerative disc, cervical spine, anterdisthesis, c6-7, herniation, c5-6, spondylosis, cervical, facet syndrome, cervical, depression secondary to industrial injury.(b)(6) 2011: the patient presented for follow-up visit.(b)(6) 2011: the patient presented with subjective complaint of seven months postop fusion, l 4-5 and l5-s1.The patient states that the fusion has helped.Ros revealed: positive for increased frequency of urination, headache, and dizziness.(b)(6) 2012: the patient underwent x-ray of lumbar spine complete including bending.Impression: stable anterior and posterior fusion l4-s1.No acute fracture of dislocation.(b)(6) 2012: the patient underwent liver biopsy.(b)(6) 2012: the patient presented for hepatology follow up.(b)(6) 2013: the patient presented with chief complaint of neck and left arm pain, back and leg pain.Ros revealed: positive for fatty liver, under treatment.The patient underwent physical examination.Impression: herniated disc, c5-6.Congenital spondylolisthesis, l5-s1, degenerated disc, l4-5, arthrodesis, l4 through s1, depression (b)(6) 2012, (b)(6) 2013: the patient presented with back, leg, neck and arm pain.Ros revealed: positive for increased frequency in urination.(b)(6) 2011: the patient underwent physical examination revealed: herniated disc c5-6, arthrodesis, l4 to the sacrum, congenital spondylolisthesis, ls-51, degenerative disc, l4-5.(b)(6) 2013: the patient presented with chief compliant of back, leg, neck and arm pain.Ros revealed: positive for cough, headache, dizziness and a fatty lever.The patient underwent physical examination.Impression: herniated disc, c5-6, arthrodesis, l4 through s1, congenital spondylolisthesis l5-s1, and degenerative disc l4-5.(b)(6) 2013: the patient presented with pre-operative diagnosis of cervical radiculopathy, cervical disc disease and cervicalgia and underwent t1-t2 cervical epidural steroid injection.(b)(6) 2013: ros revealed: : headache, dizziness.(b)(6) 2013: ros revealed: neurologic: headache, dizziness, loss of consciousness.

• 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: 5079663
• MDR Text Key: 25878950
• Report Number: 1030489-2015-02371
• 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 Catalogue Number: 7510400
• Device Lot Number: M110911AAL
• 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
• 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: 82