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

Model Number TLIFIDE420

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

Patient Problems Pain (1994); Seroma (2069)

Event Date 09/20/2023

Event Type  Injury  

Event Description

Information received from healthcare provider via manufacturer representative regarding a patient with clinical id (b)(6) and study id (b)(6).Primary diagnosis: instability description: lumbar radiculopathy onset date: (b)(6) 2023.Interventions: action subtype: ae result in hospitalization, action result: no action subtype: any other action(s) taken, action result: yes other action taken: mri ordered action subtype: did the ae result in any treatment, action result: yes action subtype: drug therapy action result: yes action subtype: physical therapy action result: yes outcome status: recovering/ resolving site seriousness assessment: there is no congenital anomaly, death, disability, hospitalization, life threatening and medical intervention, but the severity of adverse event is moderate.Site related assessment: it is not related to capstone peek spinal system, posterior supplemental fixation system, tlif grafting and possible related to transforaminal interbody lumbar fusion (tlif) procedure at l5/s1.Diagnostics: action type: diagnostic, action subtype: x-ray1, action result: normal, action date: (b)(6) 2023, action type: diagnostic, action subtype: were any diagnostic test performed, action result: yes event: it was reported that the patient right-sided back pain radiating to right buttock, right leg, stopping at the knee.Positive right slr test.2023-oct-05: additional information was received sponsor assessment (oc muo): sponsor assessed as not related to the posterior supplemental fixation system and probable related to capstone peek and possible related to procedure and tlif grafting material.Additional information was received that interventions: action subtype: physical therapy action result: yes action subtype: referral to specialist action result: yes specialist type: physiatrist diagnostics: action type: diagnostic action subtype: mri without contrast2 action result: fluid collection action date: (b)(6) 2023 it was reported that patient has right-sided back pain radiating to right buttock, right leg, stopping at the knee.Positive right slr test.Mri (b)(6) 2023: t1 hypointense, stip hyperintense signal in the right neural foramina indicative of fluid collection.Medrol dosepak and fluid aspiration + esi prescribed.Patient is taking gabapentin, tylenol and robaxin.Additional information was received site related assessment: it is probable related to tlif grafting material.Additional information was received that patient has right-sided back pain radiating to right buttock, right leg, stopping at the knee.Positive right slr test.Mri (b)(6) 2023: t1 hypointense, stip hyperintense signal in the rt neural foramina indicative of fluid collection.Medrol dose pak and fluid aspiration + esi prescribed.Patient is taking gabapentin, tylenol and robaxin.(b)(6) 2023: temporary improvement with medrol dose pak, has not done steroid injection yet.Additional information was received that interventions: action subtype: ae result in hospitalization action result: no action subtype: any other action(s) taken action result: yes other action taken: mri ordered action subtype: did the ae result in any treatment action result: yes action subtype: drug therapy action result: yes action subtype: injection action result: yes injection-1: injection name: facet steroid injection date: (b)(6) 2023 levels: l5-s1 details: and fluid aspiration attempt action subtype: physical therapy action result: yes action subtype: referral to specialist action result: yes specialist type: physiatrist it was reported that patient has right-sided back pain radiating to right buttock, right leg, stopping at the knee.Positive right slr test.Mri (b)(6) 2023: t1 hypointense, stip hyperintense signal in the right neural foramina indicative of fluid collection.Medrol dosepak and fluid aspiration + esi prescribed.Patient is taking gabapentin, tylenol and robaxin.10/27/23: temporary improvement with medrol dose pak, has not done steroid injection yet.(b)(6) 2023: had facet steroid injection and attempt at fluid aspiration rt l5/s1 on (b)(6) 2023.Site seriousness assessment medical intervention: yes additional information was received that outcome status: recovered/resolved.Outcome date 2023-11-14 it was reported that patient has right-sided back pain radiating to right buttock, right leg, stopping at the knee.Positive right slr test.Mri (b)(6) 23: t1 hypointense, stip hyperintense signal in the right neural foramina indicative of fluid collection.Medrol dosepak and fluid aspiration + esi prescribed.Patient is taking gabapentin, tylenol and robaxin.10/27/23: temporary improvement with medrol dose pak, has not done steroid injection yet.11/28/23: had facet steroid injection and attempt at fluid aspiration rt l5/s1 on (b)(6) 2023.11/29/23: resolved 11/14/23 after the injection.Additional information was received that interventions : action subtype: ae result in hospitalization action result: no action subtype: any other action(s) taken action result: yes other action taken: mri ordered action subtype: did the ae result in any treatment action result: yes action subtype: drug therapy action result: yes action subtype: injection action result: yes injection-1: injection name: facet steroid injection date: (b)(6) 2023 levels: l5-s1 details: and fluid aspiration attempt injection-2: injection name: esi date: (b)(6) 2023 levels: l5-s1 details: rt l5/s1 epidural injection action subtype: physical therapy action result: yes action subtype: referral to specialist action result: yes specialist type: physiatrist it was reported that patient has right-sided back pain radiating to right buttock, right leg, stopping at the knee.Positive right slr test.Mri (b)(6) 2023: t1 hypointense, stip hyperintense signal in the rt neural foramina indicative of fluid collection.Medrol dosepak and fluid aspiration + esi prescribed.Pt is taking gabapentin, tylenol and robaxin.10/27/23: temporary improvement with medrol dosepak, has not done steroid injection yet.Had facet steroid injection and attempt at fluid aspiration right l5/s1 on (b)(6) 2023 resolved 11/14/23 after the injection the fluid was not aspirated, no tests.

Manufacturer Narrative

H6: 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.

Manufacturer Narrative

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.

• 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: 18353685
• MDR Text Key: 330855843
• Report Number: 1030489-2023-00859
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TLIFIDE420
• Device Catalogue Number: TLIFIDE420
• Device Lot Number: M30865834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Date Device Manufactured: 06/21/2022
• 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: 52 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White