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

Model Number MSB_UNK_BMP2_ACS

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 11/03/2021

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.The following products were used in the procedure but the event was assessed as not related to the devices.This report is being submitted only for notification purpose.Product: msb_unk_bmp2_acs 1, lot: mdc4314aaa.Product 8880928 1, lot: 0758402w.Product: p1603mgs 1, lot: cccn19h7.Product: 1553201070 2, lot: unk.Product: 55840006550 4, lot: unk.Product: 55840006545 2, lot: unk.Product: 5540030 6, lot: unk.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare provider via clinical study regarding a patient with clinical id: (b)(4).Medical history: previous lumbar surgery: surgery 1: date of surgery: (b)(6) 2011 type of spinal surgery: discectomy, foraminotomy level(s): l4/l5 details: left l4-5 microdiscectomy and medial facetectomy with decompression of left l4 and l5 nerve roots.Left l4-5 microforaminotomy.Primary diagnostic indication all other diagnostic indications: instability (up to and including grade 2 spondylolisthesis, retrolisthesis or lateral listhesis) please indicate the number of consecutive levels (from l2- s1) the subject will have treated: 2 levels.Substance use: currently consume alcohol, tobacco use ex-user.It was reported that patient had csf leak due to durotomy during surgical procedure (see durotomy ae).Volume drained from hemovac (b)(6) 485ml, (b)(6) 100ml, (b)(6) 120ml.Hv removed on (b)(6), site closed with monocryl suture x1 to prevent more leakage.On (b)(6) pt was put on strict bed rest: 24 hours bed flat due to a severe csf leak.Bed rest ended on (b)(6) @7am.Onset date (b)(6) 2021  outcome status resolved outcome date (b)(6) 2021 interventions:  bed rest, hospitalization  date of admission: (b)(6) 2021  date of discharge: (b)(6) 2021  length of hospitalization: greater than 24h prolongation of existing hospitalization: yes hv removed on (b)(6), site closed with monocryl suture x1 to prevent more leakage.Site seriousness assessment: hospitalization and prolonged hospitalization.Site related assessment: not related to any devices or procedure.Sponsor assessment: casual relationship with procedure and not related to any other devices.Procedure date: (b)(6) 2021 surgical procedure: treatment group: group 1 - infuse 4.2 + mastergraft + local bone.

Manufacturer Narrative

Additional information added in b5.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

Updated information received on 07-dec-2021: interventions: per progress not 05nov2021, abdominal binder was placed to help tamponade csf leak.Sponsor assessment: usade/uade assessment: no could dd have led to sade?: not applicable updated information received on 13-dec-2021: patient¿s dob, height : in p16-03, the subject¿s date of birth was not collect, but ¿subject's age at time of informed consent¿ was collect.The subject's age at time of informed consent: 62 years and 3 months.The height was 67 inches.In p16-03, none of the subjects¿ dobs were collected, only the subject's age at time of informed consent.The date of informed consent for subject no.000142008 was 21-oct-2021.Indication for infuse : degenerative lumbar spine condition, stenosis.The subject met the inclusion and exclusion criteria for the p16-03 study.Intraoperative and post-operative details of surgical procedure: target levels: l4/l5 l5/s1 total estimated blood loss: 500 ml did a complication/adverse event prevent completion of study surgery? yes display response to 'were there any technical difficulties during surgery: no past drugs, if any : 1.Has subject used non-narcotic over the counterpain medications in last 7 days? (eg, ibuprofen) (motrin advil), naproxen (aleve), aspirin, or acetaminophen (tylenol): not at all 2 has subject used any non narcotic prescripton medications in last 7 days? (eg.Colebrex or gabapentanoids (neurotn, lynca)): often(nearly every day, 6-7 days a week) 3.Has subject used any weak narcotic medications in last 7 days? (eg.Tylenol 3, darvoort darvon, vicodin, lorce or norco): not at all 4.Has subject uses strong narcotic medications in last 7 days? (eg, percocet, percodan dilaudid, duragesk, actiq oxycontin, demerol, or kadian): often(nearly every day, 6-7 days a week) 5.Has subject used any muscle relaxants in last 7 days? (eg, flexer parafon forte, or robaxn): often(nearly every day, 6-7 days a week) concomitant medication: name, dose, route, duration of treatment, date of last dose.: in p16-03, no specific concomitant medications were collected.More information regarding the durotomy procedure: ae for durotomy is reported in pe#704702273.Any other adverse events experienced by the patient: ae for headache is reported in pe#704704030.Lab details, if any: none provided.

Event Description

Information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned. .

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.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 PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 85281
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 85281
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 12880761
• MDR Text Key: 286489858
• Report Number: 1030489-2021-01470
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• 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: MDC4314AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2023
• 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): Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White