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

Catalog Number 7510600

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

Patient Problems Muscle Spasm(s) (1966); Neuropathy (1983); Tingling (2171); Joint Disorder (2373); Inadequate Pain Relief (2388); Neck Pain (2433); Palpitations (2467)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Neither the device nor applicable imaging films were returned to the manufacturer.Therefore, cause of event cannot be determined.

Event Description

It was reported that on an unknown date the patient presented with back pain and depression which is exacerbated by movement.Per the medical records the patient underwent an x-ray of the lumbar spine.Impression: acute chronic low back pain.On (b)(6) 2007, the patient underwent an mri of the lumbar spine which demonstrated degenerative disc disease at l3-4, l4-5 and l5-s1 with midline hyperintensity on t2 at l3-4 suggestive of an annular tear.At l4-5 there was loss of disc space height, desiccation and posterior bulging.On (b)(6) 2007, the patient was admitted and was diagnosed with degenerative disc disease and herniated nucleus pulposus.The patient underwent laminectomy, complete discectomy, posterior lumbar interbody fusion utilizing local autograft, bank allograft, structural spacer and bmp.Pedicle screws and rods were also used.Per op notes: the disc spaces were appropriately sized and soaked in bacitracin irrigation for more than a minute.Each of these was packed with a bmp sponge.Autograft had been cleaned and tamped along with a small piece of bmp sponge.The right sided interbody graft was then placed to a 1-2mm countersink.There were no neurological or immediate complications.On (b)(6) 2007, the patient was discharged.On (b)(6) 2007, the patient called as he felt tingles in his left foot, his very low back and buttocks.On (b)(6) 2007, the patient presented for an office examination.He complained of muscle spasms and discomfort.He complained of numbness and tingling in the left foot, mild osteopenia is present.On (b)(6) 2007, the patient presented for an office examination.He went in verbalizing that he was miserable.He had continuous pain in his right lower extremity going from his hip down his leg.On (b)(6) 2007, the patient went for an office examination.He complained of pain in his right lower extremity, calf , medial thigh and in the entire foot.On (b)(6) 2007 , the patient called regarding pain in is right lower extremity.On (b)(6) 2007, the patient underwent lumbar myelogram and post myelographic ct scan.Findings: there are interbody devices at l3-4, l4-5 an l5-s1 levels.Definite fusion bone is not identified bridging the interspaces.There are paired pedicle screws at l3, l4, l5 and s1 with traversing fixation rods.There has been a laminectomy extending from l3 through s1.The conus is normal in position.There are no paraspinal masses.On (b)(6) 2007, the patient called regarding his continued pain in the right lower extremity, stiffness and pain in the back.On (b)(6) 2007, the patient presented with pain in the sacral area towards the right.The patient continues to experience pain in his right lower extremity that is circumferential and extensive, including the medial aspect of his foot.Emg of the right lower extremity, with some reference to the left, demonstrates a mild l5 radiculopathy.On (b)(6) 2007 , the patient called due to tearful pain , no relief with pill for depression and nerve pain.On (b)(6) 2008, the patient underwent a radiological study.Impression : extensive operative changes from l3 through s1 with bony fusion across the endplates at these levels and intact posterior orthopedic hardware without fracture or loosening.On (b)(6) 2008, the patient called regarding a ct scan which showed stable fusion at all operated levels.On (b)(6) 2009, the patient took an mri scan test.Interpretation: the signal intensity of the conus medullaris is normal.There is extensive postoperative change in the lower lumbar region with evidence of posterior rod/screw extending from l3 through s1 with paired pedicle screws at l3, l4, l5 and s1 levels.Metal artifact from this obscures detail.Conclusion: extensive postoperative changes from l3 through s1, characterized by laminectomy and spinous process removal, interbody fusion devices and posterior rod/screw fixation.Minimal diffuse disc bulging at l2-3.On (b)(6) 2011, the patient called with regards to getting a pain pump installed.On (b)(6) 2012, the patient presented with increased lbp pain and neck popping facet ds and ddd increased lbp.Procedure: implanted programmable pump refill.He was diagnosed: postlaminect synd-lumbar and cerv spondyl w myelopath.On (b)(6) 2012, the patient presented with increased pain in neck and leg , oral and it rx not working and rubbery legs.He underwent the following procedures: implanted programmable pump refill, bilateral cervical facet joint c5-6 injections with fluoroscopy.On (b)(6) 2012, the patient called due to cervical and new lumbar pain.On (b)(6) 2012, (b)(6) 2014, the patient was diagnosed with cerv spondyl w myelopath and brachial neuritis nos , sacroiliitis nec and postlaminect synd-lumbar and underwent the following procedure: implanted programmable pump refill.On (b)(6) 2012, the patient presented with inadequate pain control and feeling of rubbery legs.Procedure : reprogram implanted programmable pump.Cervical epidural steroid injection with fluoroscopy.On (b)(6) 2012, (b)(6) 2013, (b)(6) 2015, the patient presented with pain.He underwent the following procedures : implanted programmable pump refill and cervical epidural steroid injection with fluoroscopy.On (b)(6) 2013, the patient underwent c6-7 bilateral medial branch rfa and was diagnosed with brachial neuritis nos, postlaminect synd-lumbar and cerv spondyl w myelopath.He also had the following procedure: implanted programmable pump refill.On (b)(6) 2013, the patient was diagnosed with brachial neuritis nos, postlaminect synd-lumbar and cerv spondyl w myelopath and underwent the following procedure: lumbar epidural steroid injection with fluoroscopy and reprogram implanted programmable pump.On (b)(6) 2013, the patient presented with severe neck pain and underwent cervical epidural steroid injection with fluoroscopy.On (b)(6) 2013, the patient got a ct scan of the neck and shoulder.The patient also underwent a procedure to reprogram implanted programmable pump.On (b)(6) 2013, the patient administered a sacroiliac joint injection.On (b)(6) 2013, the patient underwent cervical epidural steroid injection with fluoroscopy.On (b)(6) 2013, the patient returned for follow up examination.Ros: palpitations, ankle edema, exertional sob, or exercise claudication.Musculoskeletal/neurologic: the patient entered the room with an antalgic gait.The patient complains of pain in a non dermatomal distribution of the lumbar spine.Palpation of the painful area.The patient has limited range of motion.On (b)(6) 2013, the patient presented with neck pain, cerv spondyl w myelopath and brachial neuritis nos , sacroiliitis nec and postlaminect synd-lumbar and underwent the procedure: implanted programmable pump refill.On (b)(6) 2014, the patient presented with , cerv spondyl w myelopath and brachial neuritis nos , sacroiliitis nec and postlaminect synd-lumbar and was asked to get an xray done.Ros: palpitations, ankle edema, exertional sob, or exercise claudication.Musculoskeletal/neurologic: the patient entered the room with an antalgic gait.The patient complains of pain in a non dermatomal distribution of the lumbar spine.Palpation of the painful area.The patient has limited range of motion.On (b)(6) 2014, the patient was diagnosed with sacroiliitis nec and postlaminect synd-lumbar and underwent lumbar facet joint injections with fluoroscopy.On (b)(6) 2014, the patient was diagnosed with sacroiliitis nec and postlaminect synd-lumbar and underwent lumbar facet joint injections with fluoroscopy.

Manufacturer Narrative

(b)(4).

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 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: 5024211
• MDR Text Key: 23803031
• Report Number: 1030489-2015-02046
• 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: Followup
• Report Date: 10/20/2015

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: 7510600
• Device Lot Number: M110601AAJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/29/2015
• 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 Weight: 93