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

Model Number MSB_UNK_BMP2_ACS

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

Patient Problem Neuropathy (1983)

Event Date 08/01/2023

Event Type  Injury  

Manufacturer Narrative

H3: 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.

Event Description

Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient with clinical id: (b)(6) and study id: (b)(4).It was reported that the patient experienced right lumbar radiculopathy.Patient developed right-sided radiating pain secondary to severe right foraminal stenosis at l5/s1 and degenerative tilt at l5/s1 to the right.Mri- facet arthropathy, ligamentum thickening, moderate central canal stenosis, severe right and moderately severe left foraminal narrowing at l5/s1.Moderate right foraminal stenosis at l4/l5.Patient underwent removal of hardware at l3/l5 with tlif at l2/l3 and l5/s1.Posterior fusion l2/s1 on (b)(6)2023.The number of consecutive levels (from l2-s1) that will be treated: 3 impact: referral to physiatrist for surgical treatment.L5/s1 esi ordered additional medical intervention required to prevent permanent injury or impairment: patient had in-patient or prolonged hospitalization.Patient underwent medical or surgical intervention to prevent life-threatening illness or injury, or permanent impairment to a body structure or a body function investigator assessment: related to a study procedure (tlif l3/l5), probably related to the tlif grafting material, probably related to the intervertebral body fusion device, probably related to the posterior supplemental fixation system sponsor assessment: unlikely related to procedure, possibly related to tlif grafting material, possibly related to the intervertebral body fusion device, possibly related to posterior supplemental fixation system primary diagnosis: stenosis.

• 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: 18109703
• MDR Text Key: 327880534
• Report Number: 1030489-2023-00749
• Device Sequence Number: 1
• Product Code: NEK
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2023

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 Model Number: MSB_UNK_BMP2_ACS
• Device Catalogue Number: MSB_UNK_BMP2_ACS
• Device Lot Number: M30480351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/10/2023
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White