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

Catalog Number 7510050

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

Patient Problems Pain (1994); Injury (2348); Disc Impingement (2655)

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

Patient demographics: (b)(6).It was reported per patient¿s medical records that on: (b)(6) 2010 the patient underwent cervical c5-6, cervical c6-7 anterior cervical discectomy and fusion.Preoperative diagnosis: degenerative disc disease-cervical, spinal stenosis-cervical.The patient underwent following procedures: anterior cervical discectomy and fusion c5-6 and c6-7.Anterior cervical instrumentation from c5-7.Placement of anterior interbody cages from c5-6 and c6-7.Preoperative diagnosis: cervical spinal stenosis c5-6, c6-7.As per op notes: ¿the cage was sized and the cage was placed and packed with rhbmp-2, autograft and allograft placed in the interbody space between c5-6 and c6-7.Anterior plate was fashioned and then secured to the body of c5, c6 and c7 using locking screws.¿ on (b)(6) 2010: patient presented for an office visit with diagnosis of degenerative disk disease.Assessment: patient¿s main impairments are pain, strength and joint hypomobility due to spasming.On (b)(6) 2010 the patient was presented for office visit with neck and head pain.The patient reported increasing right sided neck pain radiating up to his head severe.Impression: post operative neck pain.The patient also underwent ct scan of the cervical spine due to neck pain post surgery.Impression: c6-7 left paracentral disc herniation, protrusion, preforaminal.Otherwise satisfactory position and alignment of anterior cervical fusion.On (b)(6) 2010: patient presented for rehabilitation program with compliant of intense pain in his neck.Imaging studies revealed good placement of hardware and a swollen nerve root.On (b)(6) 2010: patient presented for continuation of his rehabilitation program.On (b)(6) 2010 the patient was presented for office visit with stress.Assessments: fatigue, stress and depression.On (b)(6) 2010 the patient underwent x rays of the cervical spine.Impression: fusion l3-4 unchanged.On (b)(6) 2010: patient underwent mri of lumbar spine without contrast.Impression: l2-3 right subligamentous disc protrusion which effaces the right l3 root and contributes to right lateral recess stenosis.Status post l3-4 transpedicular and interbody fixation without bony bridging.Midline basic protrusion and annular tear with thecal sac effacement and mild lateral recess stenosis.Status post laminectomy left.No acute vertebral fractures or instrumentation dislodgement.On (b)(6) 2010: patient underwent mri.It showed excellent fusion at the l3-l4 level but at l4-l5 he has herniated disk and has significant foraminal stenosis on the left side at the l4-l5 level.On (b)(6) 2010: patient underwent epidurography due to lower back pain.Impression: successful transforaminal lumbar epidurography and epidural steroid/ anesthesia injection at the left l4 foraminal level.On (b)(6) 2010: patient presented with chief complaint of low back, leg and previous groin pain.Assessment: radicular pain lumbar.On (b)(6) 2010: patient underwent procedure for selective epidural steroid injection and caudal epidural steroid injection.On (b)(6) 2010: patient presented for an office visit having left leg pain and weak in core.Diagnoses: lumbosacral spondylosis.Muscle weakness general.On (b)(6) 2011: the patient presented with chronic low back pain and left leg and groin pain.On (b)(6) 2011: patient underwent x-rays of lumbar spine due to indication of low back pain.Impression: surgical changes at l3-4 with degenerative changes noted at l5-s1 with facet arthropathy as well as some mild subluxation about 1 mm on flexion- extension at l2-3.The patient also underwent mri of lumbar spine.Impression: l2-3 right subligamentous disc protrusion which effaces the right l3 root and contributes to right lateral recess stenosis.Status post l3-4 transpedicular and interbody fixation without body bridging.Midline disc protrusion and annular tear with thecal sac effacement and mild lateral recess stenosis.Status post laminectomy left.No acute vertebral fractures or instrumentation dislodgement.On (b)(6) 2011: patient underwent mri of lumbar spine with and without contrast due to low back pain radiating down the left leg.Impression: status post left laminectomy and partial facetectomy l3-4 with anterior spine fusion utilizing solitary interbody cage and posterior spine fusion utilizing transpedicular instrumentation.Concentric disc displacement with superimposed central protrusion with enhancing annular rent.Mild foraminal narrowing left grater than right without nerve root compression.Cephalad to the fusion at l2-3 is a broad based protrusion with enhancing annular rent resulting in mild multifactorial central canal stenosis without nerve root compression.Caudal to the fusion at l4-5 is a shallow broad-based protrusion eccentric to the left which mildly narrows the left lateral recess and barely abuts the descending left l5 nerve root.Shallow non compressive central/ left paracentral protrusion at l5-s1.When comparison is made with previous written report and image dated (b)(6) 2010, the protrusion at the l2-3 level no longer appears to efface the descending right l3 nerve root.On (b)(6) 2011: patient presented with chief complaint of low back, leg and groin pain.Assessment: failed back lumbar.Radicular pain lumbar.Lumbar facet syndrome.On (b)(6) 2011: patient presented with pre-op diagnosis as lumbar radiculopathy.For which patient underwent following procedures: placement of 16 electrode spinal cord stimulator lead.Oral antibiotic.Oral sedation.Fluoroscopy.Complex programming of spinal cord stimulator leads.Patient tolerated the procedure well with no complications reported.On (b)(6) 2011: patient underwent removal of spinal cord stimulator lead removal.Patient identifies no pain relief with the stimulator.Assessment: failed back lumbar.Radicular pain lumbar.Lumbar facet syndrome.On (b)(6) 2011: patient presented with complaint of low back pain and groin pain.On (b)(6) 2011, the patient was diagnosed with herpes zoster.On (b)(6) 2011: the patient presented for follow-up with sharp and stabbing pain in low back and legs.On (b)(6) 2011, the patient underwent ct chest, abdomen and pelvis with contrast.Impression: chest:left 7th-9th rib fractures with mode rately-size pneumothorax and subcutaneous emphysema.Abdomen and pelvis: no traumatic injury.On (b)(6) 2012: the patient presented with sharp and stabbing pain in the low back, left side.He also complained of leg pain.The patient underwent leads removal of the spinal cord stimulator trial, which was implanted on (b)(6) 2011.As there was no relief, the patient did not want implant.On (b)(6) 2012: patient presented with chief complaint of low back and leg pain.Assessment: failed back lumbar.Radicular pain lumbar.Lumbar facet syndrome.On (b)(6) 2012: patient presented with pre-op diagnosis as lumbar facet syndrome.For which patient underwent branch radiofrequency ablation under fluoroscopic guidance.Patient tolerated the procedure well with no complications reported.

• 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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6699621
• MDR Text Key: 79583215
• Report Number: 1030489-2017-01710
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00613994239518
• UDI-Public: 00613994239518
• 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: 06/12/2017

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: 11/01/2010
• Device Catalogue Number: 7510050
• Device Lot Number: M110906AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/12/2017
• Initial Date FDA Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2009
• 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 Age: 44 YR
• Patient Weight: 87