MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE® BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P

Model Number 7510200

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

Patient Problems Abscess (1690); Bacterial Infection (1735); Unspecified Infection (1930); Pain (1994); Cramp(s) /Muscle Spasm(s) (4521); Intervertebral Disc Compression or Protrusion (4524); Swelling/ Edema (4577)

Event Date 08/03/2023

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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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

Information was received from a (regulatory body, patient, health care professional) via manufacturer representative regarding a patient who was implanted with infuse and cage.It was reported that patient had spinal surgery to implant a spacer on 2023 to relieve pressure between l3-4.Two devices were implanted in spine lumbar.Post op, bacterial infection was diagnosed upon admission to hospital.Patient had experienced severe pain and spasms since surgery and mri was conducted and found that there was status post interbody spacer at l3-4 with edema in the disc space, adjacent vertebral bodies, ventral epidural space and psoas muscle with apparent left psoas abscess.It was also found that findings are concerning for discitis osteomyelitis.Patient had been hospitalized and treated with broad spectrum iv antibiotics and released with picc line installed to continue iv antibiotics for 6-8 weeks.Due to lab error, the bacteria was not speciated and there was no original specimen left to do so from before antibiotics were administered in the hospital.Event stated as life threatening and require intervention.There were no further complications that were reported.Additional information received that mri of the lumbar spine was performed with multiple sequences performed in sagittal and axial planes on a 1.5 tesla magnet.Study was performed before and after the administration of 20 cc of clariscan.Mri findings: vertebral body heights: maintained.Alignment: grade1 retrolisthesis of l3 on l4 and l4 on ls.Marrow signal: no acute fracture or marrow replacing lesion is seen spinal canal: the conus terminates at l 1 and is unremarkable paravertebral soft tissues: unremarkable.No abnormal enhancement discs: there was degenerative decreased t2 disc signal from l3-4 through l5-s1 l1-2: there was no significant posterior disc abnormality, spinal canal or foraminal stenosis.L2-3: there was diffuse disc bulging impinging the descending right l3 nerve roots with moderate bilateral foraminal narrowing l3-4: there was diffuse disc bulging, laminectomy and superimposed and right foraminal disc herniation resulting in moderate left severe right foraminal narrowing compressing exiting right l3 nerve roots l4-5: there is diffuse disc bulging eccentric to the left resulting in moderate left greater than right foraminal narrowing l5-s1: there was diffuse disc bulging, right paracentral annular fissure and facet arthropathy resulting in mild foraminal narrowing conclusion: stable severe right l3-4 foraminal narrowing compressing exiting right l3 nerve roots.Standing ap and lateral x ray findings: comparison was made with (b)(6) 2023 and (b)(6) 2023 there were no acute fractures.Cortical margins are intact.Vertebral body heights are well-maintained.There had been bilateral laminectomies l3 and l4 levels.There was mild diffuse disc space narrowing with moderate to marked multilevel osteophyte formation.Facet joints are unremarkable.There is no evidence of spondylolysis vertebral alignment is normal.There is moderate bilateral sacroiliac degeneration.Lumbar lordotic curve is normal.Bilateral total hip arthroplasties are present conclusion: bilateral laminectomies l3 and l4 levels and moderate multilevel lumbar degenerative changes.Patient medical history: lower back pain with right sciatica, lower back pain with left sciatica upper and lower extremity pins and needles, numbness lower/upper extremity, right leg pain, difficulty walking.Lower back pain, spinal stenosis, lumbar region without neurogenic claud, spasm of back muscles, lower back pain with right sciatica spinal fusion.

• Brand Name: INFUSE® BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P
• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 17894039
• MDR Text Key: 325238576
• Report Number: 1030489-2023-00686
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843782
• UDI-Public: 00681490843782
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7510200
• Device Catalogue Number: 7510200
• Device Lot Number: MGP7850AAA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2023
• Date Device Manufactured: 05/05/2023
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 66 YR