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

Catalog Number 7510200

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

Patient Problems Chest Pain (1776); Fainting (1847); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Neuropathy (1983); Stenosis (2263); Depression (2361); Numbness (2415); Neck Pain (2433); Palpitations (2467); 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.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

Patient demographics: (b)(6).It was reported that on(b)(6) 1998, patient underwent following procedure: bilateral posterolateral fusion l4-5; bilateral posterolateral fusion l5-s1; posterior lumbar interbody fusion l4-5; posterior lumbar interbody fusion l5-s1; posterior segmental spinal instrumentation l4 to the sacrum; left posterior iliac crest bone graft harvest, autologous, morcellized; insertion of epidural catheter for postoperative analgesia; insertion of intervertebral body cages; exploration of right l4-5 far lateral area.Pre-op diagnosis: degenerative disk disease l4-5, l5-s1 with right far lateral disk herniation at l4-5.No complications were reported.On(b)(6) 2002, patient underwent following procedure: removal of posterior segmental spinal instrumentation; exploration of lumbar fusion l4 to the sacrum; posterior pseudoarthrosis repair/posterolateral fusion l4-5; posterior segmental spinal instrumentation l4-5; left posterior iliac crest bone graft harvest, morcellized, autologous; insertion of epidural catheter for postoperative analgesia.For a pre-op diagnosis : probable ps eudoarthrosis l4-5; retained spinal hardware.On (b)(6) 2005, patient presented for follow up two weeks status post anterior discectomy and fusion c6-7.Radiographs showed plate and screws to be well maintained in excellent position.Graph position good.Overall spinal alignment was good.On (b)(6) 2005, patient underwent following procedure: anterior cervical diskectomy, c6-7 with decompression of the spinal canal and bilateral c7 foraminotomy anterior cervical fusion, c6-7 anterior cervical plate fixation, c6-7 application and removal of gardner-wells tongs use of allograft iliac crest bone graft.For pre-op diagnosis of cervical disk herniation, c6-7.The areas between the size of the graft and the vertebral bodies were then also grafted with rhbmp-2.On (b)(6) 2005, patient presented for follow up 3 weeks post acdf at c6-7.Patient reported cervical-thoracic junction neck pain.X-rays show hardware in stable position and alignment.On (b)(6) 2005, patient presented for follow up 2 months post acdf at c6-7.Ap and lateral views of the cervical spine show excellent hardware positioning and healing bone graft.On (b)(6) 2006, patient presented for follow-up 4 months postoperative anterior discectomy and fusion c6-7.Flexion/extension lateral cervical x-rays showed a solid appearing fusion with implants stable and no motion present.Upper and lower motion segments appear to be healthy.On (b)(6) 2008, patient presented for follow-up for low back pain, hypertension, anxiety and depression.On (b)(6) 2008, patient presented for follow-up for low back pain, hypertension, anxiety and depression.On (b)(6) 2009, patient presented for follow-up for low back pain, hypertension, anxiety and depression.On (b)(6) 2009, patient presented for a follow up on his lumbar and cervical fusions.Patient reported numbness and pain in his right upper extremity that radiates down to his wrist and continuous back pain.Patient reported spasms are sharp and stabbing and ache bilaterally into his hips.He experiences lower extremity numbness, greater on the right than on the left, that radiates to the dorsum of the feet.Patient was unable to work and was on permanent disability.Patient had eight epidural injection for lumbar spine without any benefit.On (b)(6) 2009, patient reported severe low back and bilateral hip pain, right greater than left with discomfort radiating down his legs, right greater than left related to standing, particularly after a period of prolonged sitting.Mri of the lumbar spine showed fairly advanced stenosis right greater than left at l3-4 above his solid fusion, moderate degenerative disease at this level.Flexion/extension x-rays show retrolisthesis of l3-4 on extension, neutral alignment inflexion.Solid fusion below 3dtsr.Hardware present at l4-5.On (b)(6) 2009, patient presented for follow-up for low back pain, hypertension, anxiety and depression.On (b)(6) 2009, patient underwent following procedure: hardware removal from lumbar spine; exploration of lumbar fusion at l4-5; l3 laminectomy with bilateral l3-4 medial facetectomies and foraminotomies; l3-4 posterolateral fusion; l3-4 posterior lumbar interbody fusion; posterior instrumentation at l3-4; insertion of intervertebral cage at l3-4; use of local bone graft, rhbmp-2, and bone graft matrix; bilateral lower extremity triggered emg monitoring.Pre-op diagnosis was: painful retained lumbar hardware; lumbar spinal stenosis; degenerative instability at l3-4, adjacent segment to degeneration.No complications were reported as a result of this surgery.Per op notes: the disk space was grafted with a composite of rhbmp-2 and bone graft followed by insertion of an appropriate sized crescent cage made of peek filled with rhbmp-2.On (b)(6) 2009, patient presented for follow-up 2 weeks' postoperative lumbar fusion at l3-4.Patient reported bilateral arm numbness.Radiographs show his implant stable in position, overall alignment well maintained.On (b)(6) 2009, patient underwent comprehensive counseling for hardware removal, l3 laminectomy, l3-4 posterior lumbar interbody fusion with instrumentation, cage, and bone graft.On (b)(6) 2009, patient presented for follow up two months post lumbar fusion of l3-4.Patient reported left hip and lower back pain.Plain radiograph films of the lumbar spine, ap and lateral, showed the hardware well placed, stable, and in position with no other acute findings.On (b)(6) 2009, patient presented for follow-up for low back pain, hypertension, anxiety and depression.On (b)(6) 2009, patient presented for follow-up and refill of medication for low back pain, hypertension, anxiety and depression.On (b)(6) 2009, patient presented for follow-up for low back pain, hypertension, anxiety and depression.On (b)(6) 2009, patient presented for follow-up for low back pain, hypertension, anxiety and depression.On (b)(6) 2009, patient presented for follow-up and medication fill up for low back pain, hypertension, anxiety and depression.On (b)(6) 2010, patient underwent x-ray.Impression: no acute fracture or dislocation of foot.On (b)(6) 2010, patient presented with right ankle fracture, patient reported a fall and twisted his right lower extremity.He experienced immediate lateral right ankle pain and noted deformity.Patient underwent x-ray of right ankle, impression: right ankle bimalleolar equivalent with displaced distal fibular diaphyseal fracture.Doctor recommended surgery for the fracture.Prior to fracture patient used cane for ambulation.On (b)(6) 2010, patient presented for follow-up for low back pain, hypertension, anxiety and depression.On (b)(6) 2010, patient presented for follow up post orif of right distal fibula.Patient underwent ap, lateral, and mortise view x-rays of the right ankle, impression: status post orif, right ankle lateral malleolus (weber c) fracture doing well.Early crps.On (b)(6) 2010, patient presented for follow up post orif of right distal fibula.On (b)(6) 2010, patient presented for follow-up for low back pain, hypertension, anxiety and depression.On (b)(6) 2010, patient presented for follow up post orif of right distal fibula.On (b)(6) 2010, patient presented for follow up post orif of right distal fibula.On (b)(6) 2010, patient presented for follow-up for low back pain, hypertension, anxiety and depression.On (b)(6) 2010, patient reported back pain and depression.On (b)(6) 2010, patient presented with persistent spinal complaints, plain radio graph films of the cervical area showed a well-healed fusion, no additional findings noted, no proximal adjacent segment degenerative changes.Lumbar films, ap and lateral, showed an unconvincing fusion with minimal intervertebral ossification.The thoracic area does showed some degenerative changes, ddd, and vertebral height loss.On (b)(6) 2010, patient presented for follow up presented for follow-up for low back pain, hypertension, anxiety and depression.Patient underwent thoracic mri.Patient reported lower back pain and a sensation of instability in the area that was not resolved from his previous fusion approximately one year ago.Mri of the thoracic area showed some stenosis at t4-5 and ts-6, which is consistent with his symptoms.On (b)(6) 2010, patient presented for follow-up for low back pain, hypertension, anxiety and depression.Post epidural injections pain was better.On (b)(6) 2011, patient presented for a follow up for low back pain, hypertension, anxiety and depression.On (b)(6) 2011, patient presented for a follow up for low back pain, hypertension and depression.On (b)(6) 2011, patient presented for a follow up for low back pain, hypertension and depression.On (b)(6) 2011, patient reported getting dizzy and passing out followed by palpitation and pain in chest.Patient underwent x-ray which shoed clear lungs with normal pulmonary vessels.On (b)(6) 2011, patient presented for follow up and reported hallucinating.Patient was in hospital for fainting.On (b)(6) 2011, patient presented for a follow-up and getting refill of medication and reported low back pain.On (b)(6) 2011, patient presented for a follow-up and getting refill of medication.On (b)(6) 2011, patient was involved in a mvc and reported pain in neck, lower thoracic and upper lumbar spine, pelvis, upper and lower leg and right ankle.On (b)(6) 2011, patient underwent x-ray after mvc.Impression: stable findings, no evidence of acute traumatic injury.On (b)(6) 2011, patient was involved in mvc on (b)(6) 2011, and reported pain in back, neck and teeth after accident.Patient underwent ct which showed fusion instrumentation in stable position and no fractures were observed.On (b)(6) 2011, patient reported with back pain which had worsened since accident.On (b)(6) 2012, patient reported chronic pain due to trauma.On (b)(6) 2012, patient presented for follow up for depression.On (b)(6) 2012, patient presented for follow up for back pain.On (b)(6) 2012, patient presented for follow-up.On (b)(6) 2012, patient presented for follow-up.Patient had a car accident and had neck, rib and backpain due to accident.

• 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: 5045140
• MDR Text Key: 24724671
• Report Number: 1030489-2015-02145
• 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
• Report Date: 08/03/2015

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 Expiration Date: 10/30/2007
• Device Catalogue Number: 7510200
• Device Lot Number: M114006AAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2015
• 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): Required Intervention
• Patient Weight: 113