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

Catalog Number 7510800

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

Patient Problems Pain (1994); Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

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.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) 1999: the patient was pre-operatively diagnosed with central herniated disk l4-l5 and underwent partial bilateral l4-l5 hemil aminectomy, diskectomy and foraminotomy with microsurgical technique.(b)(6) 2009: the patient presented for lumbar spine mri at the hospital.Impressions: segmentation error with sacralized l5; multilevel degenerative discogenic changes l1-l2 through l4-l5; bulging disc at l1-l2, l2-l3, l3-l4; lateral recess narrowing for the l4 and l5 roots resulting from bony facet hypertrophy.(b)(6) 2009: the patient presented for follow up visit at the hospital.Impressions: degenerative spondylolisthesis l3-l4 and l4-l5, status post previous two laminectomies; bilateral foraminal central stenosis l3-l4 and l4-l5; advanced severe foraminal stenosis l4-l5 on left side; plantar fasciitis.(b)(6) 2009: the patient was pre-operatively diagnosed with lumbar spinal stenosis and underwent following procedure: l3-l4, l4-l5 direct lumbar interbody fusion with minimally invasive surgery; posterior instrumentation spinal fusion.Patient underwent surgery using rhbmp-2/acs.The patient was pre-operatively diagnosed with spinal disk disease at l3-l4 and anterior spinal exposure for spinal fusion at l3-l4 and l4-l5 was performed.The patient was pre-operatively diagnosed with degenerative disc disease lumbar spine and underwent l3-l4 and l4-l5 direct lumbar interbody fusion with bilateral facet screws and left sided l4-l5 laminectomy/foraminotomy.Rhbmp-2 was used in the fusion surgery.(b)(6) 2009: the patient complained of pain in leg.(b)(6) 2009: the patient underwent neurological, musculoskeletal assessment.The patient complained of acute pain in back, leg.(b)(6) 2010: the patient was diagnosed with cervical facet arthritis.(b)(6) 2010: the patient presented for follow up visit at the hospital.Impressions: c5-c6 cervical disk herniation; c5-c6 cervical spinal stenosis; c5-c6 foraminal stenosis right side.

• 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: 6696358
• MDR Text Key: 79388633
• Report Number: 1030489-2017-01703
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843829
• UDI-Public: 00681490843829
• 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

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2011
• Device Catalogue Number: 7510800
• Device Lot Number: M110808AAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2009
• 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 Weight: 99