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

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

Patient Problem Hematoma (1884)

Event Date 04/30/2018

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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that post-op, patient had spinal hematoma secondary to spinal fusion surgery.Intervention was required due to this event and prolonged hospitalization.Event was surgical procedure related.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Primary diagnosis: primary diagnostic indication: instability (up to and including grade 2 spondylolisthesis, retrolisthesis or lateral listhesis); stenosis with documented pre-operative instability; recurrent disc herniation; concomitant lumbar degenerative deformity (cobb angle <(><<)> or equal to 30 degrees) the patient had underwent posterior lumbar fusion at l2-l5 with l4-l5 transforaminal lumbar interbody fusion.Post-op, recurrent atrial fibrillation was reported with rapid ventricular rate and pre-existing atrial fibrillation now worsened.Severity: severe site sae: yes ae outcome: pending pregnant since last visit 24_months: has the subject become pregnant since last visit: na date of visit: (b)(6) 2020 usade/uade assessment: no could dd have led to sade? - not applicable cancer was also diagnosed: date of diagnosis as related to patient's cancer: (b)(6) 2019 date of pathology report: (b)(6) 2020 cancer results: records pending location/type of cancer: prostate cancer-report pending family history of cancer: na lab work: na medications taken within 30 days of cancer diagnosis: na.

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.

Event Description

Date of diagnosis of cancer: (b)(6) 2020 (corrected from (b)(6) 2019) date of pathology report: (b)(6) 2020 (corrected from (b)(6) 2019) cancer results: (b)(6) positive for adenocarcinoma; the left mid lateral and left medial showed gleason 4+4=8 prostate cancer and the right base medial showed 3+3=6 prostate cancer.Family history of cancer: na lab work: yes lab date: (b)(6) 2019 lab result: elevated psa at 4.25 medications taken within 30 days of cancer diagnosis: na.

Manufacturer Narrative

Additional information: b5, g1, g2, g5.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; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7680308
• MDR Text Key: 113742476
• Report Number: 1030489-2018-00982
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/23/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 07/11/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 05/22/2020; 07/21/2020
• Supplement Dates FDA Received: 10/04/2018; 06/20/2020; 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 98