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

Model Number SEE H10

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

Patient Problem Pain (1994)

Event Date 06/01/2021

Event Type  Injury  

Event Description

The information was received from a clinical study with clinical patient id: (b)(6) and study id (b)(4) for spinal therapy.It was reported that the patient had buttock pain (new pain & location).Interventions action subtype: drug therapy; action result: y action subtype: other relevant actions; action result: y outcome status pending patient details: randomization assignment: 4.2mg of rhbmp-2 randomization date: (b)(6) 2019 number of levels to be treated: 3 levels pregnant since last visit 6_weeks: has the subject become pregnant since last visit: na.Date of visit: (b)(6) 2020.Pregnant since last visit 3_months: has the subject become pregnant since last visit: na.Date of visit: (b)(6) 2020 pregnant since last visit 6_months: has the subject become pregnant since last visit: na.Date of visit: (b)(6) 2020.Pregnant since last visit 12_months: has the subject become pregnant since last visit: na.Date of visit: (b)(6) 2020.Pregnant since last visit 24_months: has the subject become pregnant since last visit: na.Date of visit: (b)(6) 2021.Site seriousness assessment: uade: n site related assessment: the assessment is not related to any part and was related to surgical construct and/or study procedure and probable related to surgical procedure.Sponsor assessment: usade/uade assessment : no; could dd have led to sade? not applicable sponsor assessment: the assessment is not related to any part and was probable related to surgical procedure and procedure.On (b)(6) 2019 adverse event document number(s) associated with additional surgery: document number: (b)(4) subevent number: 0 describe the additional surgical procedure: stenosis at l2-3 and hematoma that was compressing the l3-s1 thecal sac in the region of prior decompression.All of the thecal sac was fully decompressed with no remaining hematoma.Additional surgery: (b)(6) 2019 levels involved in additional surgical procedure: l2/l3, l3/l4, l4/l5, l5/s1 surgical procedure to surgical construct and/or the study procedure: related plf grafting material related to surgical construct and/or surgical procedure: not related posterior fixation related to surgical construct and/or surgical procedure: not related interbody fusion related to surgical construct and/or surgical procedure: not related surgical procedure related to surgical construct and/or surgical procedure: causal relationship surgical procedure: (b)(6) 2019 spinal.Surgeon last name: (b)(6).Treatment group: group 1 - infuse 4.2 + mastergraft + local bone previous lumbar surgery.Surgery 1: date of surgery: (b)(6) 2015.Type of spinal surgery: laminectomy level(s): l2/l3; details: l2-3 decompression primary diagnostic indication: all other diagnostic indications: stenosis with documented pre_operative instability.Please indicate the number of consecutive levels (from l2-s1) the subject will have treated: 3 levels.

Manufacturer Narrative

Other: left-sided lowback pain.The following products were used in the surgery: product id: p1603m, lot#: mmx99382aap, qty.: 1, pma: p000058, udi: (b)(4).Product id: 55840007560, lot#: h5568769, qty.: 2, 510(k): k113174, udi: (b)(4).Product id: 55840007555, lot#: h5557395, qty.: 1, 510(k): k113174, udi: (b)(4).Product id: 5540130, lot#: h5556147, qty.: 4, 510(k): k113174, udi: (b)(4).Product id: 5540130, lot#: h5436979, qty.: 4, 510(k): k113174, udi: (b)(4).Product id: 1553201080, lot#: unk, qty.: 1, 510(k): k113174, udi: (b)(4).Product id: p1603m, lot#: m111814aah, qty.: 1, pma: p000058, udi: (b)(4).Product id: 2990726, lot#: h5079379, qty.: 1, 510(k): k073291, udi: (b)(4).Product id: 2990726, lot#: h5519434, qty.: 1, 510(k): k073291, udi: (b)(4).Product id: p1603mgs, lot#: cccn19h7, qty.: 2, udi: (b)(4).Product id: 1553201090, lot#: 0576966w, qty.: 1, 510(k): k113174, udi: (b)(4).Product id: 55840007550, lot#: h5526815, qty.: 2, 510(k): k113174, udi: (b)(4).Product id: 55840007560, lot#: h5554204, qty.: 3, 510(k): k113174, udi: (b)(4).Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose.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.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Section b5: additional information updated.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

The information was received from a clinical study with clinical patient id: (b)(6) and study id (b)(6) / p16-03 for spinal therapy.It was reported that the patient had buttock pain (new pain location).Interventions action subtype: drug therapy; action result: y action subtype: other revelant actions; action result: y outcome status pending patient details: randomization assignment: 4.2mg of rhbmp-2 randomization date: (b)(6) 2019 number of levels to be treated: 3 levels pregnant since last visit 6_weeks: has the subject become pregnant since last visit: na date of visit: (b)(6) 2020 pregnant since last visit 3_months: has the subject become pregnant since last visit: na date of visit: (b)(6) 2020 pregnant since last visit 6_months: has the subject become pregnant since last visit: na date of visit: (b)(6) 2020 pregnant since last visit 12_months: has the subject become pregnant since last visit: na date of visit: (b)(6) 2020 pregnant since last visit 24_months: has the subject become pregnant since last visit: na date of visit: (b)(6) 2021 site seriousness assessment: uade: n site related assessment : the assessment is not related to any part and was related to surgical construct and/or study procedure and probable related to surgical procedure.Sponsor assessment: usade/uade assessment : no; could dd have led to sade? not applicable sponsor assessment: the assessment is not related to any part and was probable related to surgical procedure and procedure.(b)(6) 2019 adverse event document number(s) associated with additional surgery: document number: (b)(4) subevent number: 0 describe the additional surgical procedure: stenosis at l2-3 and hematoma that was compressing the l3-s1 thecal sac in the region of prior decompression.All of the thecal sac was fully decompressed with no remaining hematoma.Additional surgery : (b)(6) 2019 levels involved in additional surgical procedure: l2/l3, l3/l4, l4/l5, l5/s1 surgical procedure to surgical construct and/or the study procedure: related plf grafting material related to surgical construct and/or surgical procedure: not related posterior fixation related to surgical construct and/or surgical procedure: not related interbody fusion related to surgical construct and/or surgical procedure: not related surgical procedure related to surgical construct and/or surgical procedure: causal relationship surgical procedure: (b)(6) 2019 spinal surgeon last name: michael treatment group: group 1 - infuse 4.2 + mastergraft + local bone previous lumbar surgery 1: date of surgery: (b)(6) 2015 type of spinal surgery: laminectomylevel(s): l2/l3 ; details: l2-3 decompression primary diagnostic indication: all other diagnostic indications: stenosis with documented pre_operative instability please indicate the number of consecutive levels (from l2-s1) the subject will have treated: 3 levels additional information received states that the patient had left buttock pain (new pain location).Sponsor assessment: usade/uade assessment: no.

• 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: 12494650
• MDR Text Key: 282348280
• Report Number: 1030489-2021-01180
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2021

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 Expiration Date: 02/28/2021
• Device Model Number: SEE H10
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 12/01/2021
• Supplement Dates FDA Received: 12/05/2021
• Date Device Manufactured: 04/01/2019
• 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 Sex: Male
• Patient Weight: 106 KG