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 Arthritis (1723); Neuropathy (1983); Loss of Range of Motion (2032); Weakness (2145); Burning Sensation (2146); Tingling (2171); Discomfort (2330); Ambulation Difficulties (2544)

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

Levels: l5-s1 it was reported that on (b)(6) 2006, the patient underwent spine fusion surgery from vertebrae l5 - s1, where only rhbmp-2 and collagen sponge were used.Post-op, patient had relief in initial period but progressively patient experienced worsening low back pain with radiculopathy, numbness, tingling and weakness in the lower left extremities.Patient continued to experience debilitating low back pain, with radiculopathy into lower left extremities.The patient suffered sharp intermittent spurts of pain on the left lumbar spine and a constant burning pain and weakness down to left buttock and leg.The patient also experienced daily difficulties, including but not limited to, challenges walking beyond short distances, discomfort standing after a few minutes, trouble going up or down stairs, and problems getting out of a chair.These serious injuries prevent the patient from practicing and enjoying the activities of daily life that patient enjoyed pre-operatively, and had otherwise suffered serious and permanent injuries.

Manufacturer Narrative

Additional information: pt identifier, weight, relevant tests/lab data, other relevant history, model and lot #, evaluation codes.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2002: the patient presented with a chief complaint of pain in the left lumbar region with the pain extending into the left hip, posterior thigh and into the plantar aspect of his foot.On (b)(6) 2003,(b)(6) 2004: the patient presented with a chief complaint of pain in lower lumbar spine and numbness/tingling.On (b)(6) 2004: the patient presented with a chief complaint of increasing pain in the lower lumbar spine region for past two weeks and denied any injury.Patient stated the pain radiates into the left buttock, posterior/lateral thigh and calf into the heel of his foot.Patient also complained of muscle tightness of the lumbar spine and inability to extend himself.On (b)(6) 2004: the patient presented with a chief complaint of axial lumbar spine, complaints in the left lower extremity including pain, numbness and tingling.The patient was diagnosed with degenerative disc disease, post operative lumbar spine discectomy, recurrent left iliac crest and radicular path.On (b)(6) 2005: the patient presented with a chief complaint of left leg pain radiating down left buttock, thigh, posterior calf and foot along the heel and lateral aspect of the foot to the bottom of the foot.The patient underwent x-ray with impressions: lumbar disc disruption/lumbosacral radiculopathy/post laminectomy syndrome.The patient underwent left l5-s1 transforaminal epidural steroid injection accompanied by left s1 nerve root injection under fluoroscopic guidance.On (b)(6) 2005: the patient presented for follow up for epidural steroid injection at l5-s1 due to lumbar axial pain.On (b)(6) 2006: the patient presented for follow up for back pain and left leg pain.On (b)(6) 2006: the patient underwent mri of lumbar spine with and without contrast due to radiating back pain from left side to left foot.Impressions: recurrent left paracentral disc extrusion at l5-s1 causes compression of the left s1 nerve root.The patient is status post left laminotomy and there is mild epidural fibrosis surrounding the extruded disc fragment.Mild bilateral foraminal stenosis is due to a mild diffuse disc bulge and mild facet arthropathy, but there is no compression of the dorsal root ganglia.On (b)(6) 2006: the patient presented for follow up for back pain and mri.On (b)(6) 2006: the patient presented for chest pa and lateral.Impression: negative chest.On (b)(6) 2006: the patient presented with a pre-op diagnosis of third time recurrent herniation at left l5-s1, severe disc degeneration l5-s1 and bilateral foraminal stenosis l5-s1.The patient underwent following procedure: lumbar laminectomy, foraminotomy, inferior facetectomy l5-s1.Transforaminal discectomy l5-s1.Anterior interbody cage placement l5-s1.Posterolateral interbody fusion with local bone graft and fresh frozen cancellous allograft l5-s1.Posterior spinal fusion with segmental instrumentation.As per op-notes¿ a complete laminectomy, foraminotomy, inferior facetectomy were completed at l5-s1.There was an obvious recurrent herniation on the left at l5-s1.A transforaminal discectomy was completed using curets, rongeurs and disc shavers.The end plate cartilage was removed with curets.Entry into the dorsal aspect of the pedicel of l5 and s1 was carried out bilaterally with a 4mm bur.Decortication of the transverse process at l5 and sacral alum bilaterally was carried out with a bur.Also, the facet joints of l5-s1 were curetted.The cage was filled with bone morphogenic protein and inserted into the anterior column.A posterolateral interbody fusion was then completed using local bone graft and fresh frozen cancellous allograft.Also, the 6.5 x 45mm screws were placed at l5 bilaterally with 7.5 x 40mm screws inserted at s1 bilaterally.The posterolateral gutters were filled with the same bone graft material and the 6.35mm rod was placed over the top loading screws.Intra-operative x-ray showed good position of all implants.The patient tolerated the procedure well.No intra-operative complications were noted.¿ the patient also underwent a lateral view of lumbar spine due to low back pain.Impression: l5-s1 disc narrowing.On (b)(6) 2006: the patient presented for follow up for back pain and bilateral hip pain.Patient¿s pain was intensifying by lying down or sitting and was diminished by rest.On (b)(6) 2006: the patient presented for a follow up visit for back, left hip and left lower extremity.The patient had complaints in left lower extremity including pain, numbness, tingling and weakness.On (b)(6) 2007: the patient presented with a chief complaint of back pain.Pain was intensified by walking too much and is diminished by rest.On (b)(6) 2007: the patient presented with a complaint of intermittent low back pain and left hip pain with numbness in the left foot.On (b)(6) 2013: the patient presented for a follow up visit for axial lumbar spine including pain and decreased range of motion.The patient had complaints in left lower extremity including pain, numbness, tingling and weakness.Patient stated symptoms were worse than onset.On (b)(6) 2013: the patient presented for ct scan of lumbar spine due to low back pain, transition syndrome and facet arthrosis of the left lower extremity radiculopathy.Impression: anterior and posterior fusion l5-s1 appears satisfactorily healed.Non-operative l4-l5 facet levels demonstrate mild arthritic changes bilaterally.The patient also underwent mri of lumbar spine due to lumbosacral neuritis and spondylosis.Impression: satisfactory post procedural appearance at the l5-s1 level.Left neural foramen is not well visualized due to susceptibility artifact.On (b)(6) 2014: the patient presented for follow up lumbar ct and mri and re-evaluation of condition, complaints of the axial lumbar spine include pain, left lower extremity including pain, numbness, tingling and weakness.On (b)(6) 2014: the patient presented with a pre-op diagnosis of degenerative disc disease l1-l2-l5-s1, facet arthrosis l3/4-l5/s1, low back pain, degenerative lumbar scoliosis, myofascial pain syndrome, lumbar radiculopathy bilaterally, leg pain and stenosis lumbar.Hence, patient underwent fluoroscopically guided diagnostic intra-articular facet injection: bilateral l4-s.On (b)(6) 2014: the patient presented for a follow up diagnostic of bilateral l4-5 facet injection and re-evaluation of condition.The patient visited with a chief complaint of axial lumbar spine including pain, left lower extremity including pain, numbness, tingling and weakness.On (b)(6) 2015: the patient presented with persistent left leg pain with palpation over the hardware particularly on the left side.The patient diagnosed with painful retained hardware at l5-s1.Hence, underwent microscopic and navigation-assisted surgery and left l5-s1 hardware removal.Patient presented with a screw of the s1 which protrudes anteriorly and probably impacting the l5 nerve root and probably the reason for continued left leg pain.As per op-notes¿ starting on the left side, they carried out a 2cm skin incision over the hardware.Muscle dilaters inserted, followed by placement of tubular retractor attached to an arm mount on the table.The hardware was identified.The extra bone formation was debrided around the hardware.The set screws were removed.The rod was removed.The pedicle screws were removed without difficulty.The wound was irrigated.No bleeding was noted.The retractor was removed.The patient was awakened, extubated and taken to the recovery room in satisfactory condition having tolerated the procedure well¿.

• 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: 5154430
• MDR Text Key: 28443595
• Report Number: 1030489-2015-02697
• 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: 04/04/2016

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7510400
• Device Lot Number: M115009AAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2016
• 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: 104