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

Catalog Number SEE-H10

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

Patient Problem Pain (1994)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

The following products were used in the surgery: product id: 7510800, lot#m111804aaa, udi# (b)(4), pma# (b)(4), qty: 2 product id: 55840006550, lot#h5471256, udi# (b)(4), 510k: k113174,qty: 7 product id: 5540130, lot#h5545769, udi# (b)(4), 510k: k113174, qty: 8 product id: 2991122, lot#h5473531, udi#(b)(4), 510k: k073291, qty: 1 product id: 1553201090, lot#0701342w, udi#(b)(4), 510k: k113174, qty: 2 product id: p1603mgs, lot#cccn16l4, qty: 2.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.

Event Description

Pre-op diagnosis: concomitant lumbar degenerative deformity (cobb angle <(><<)> or equal to 30 degrees) procedure: l5/s1 transforaminal lumbar interbody fusion (tlif) level treated: from l2- s1; target levels: l3/l4 , l4/l5 and l5/s1 it was reported that on (b)(6) 2019, post-op, the patient was suffered from low back pain, buttock pain and more tightness than pain as per patient.As per site assessment, this event is not related with the devices but related and unlikely related with surgical construct and/or study procedure and surgical procedure simultaneously.As per sponsor relatedness assessment, this event is not related with the devices but unlikely related with surgical procedupres.Discharge date: (b)(6) 2019 outcome of the events is still unresolved.No diagnostic tests were performed relevant to this adverse event.

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.

Event Description

Updated information received on 04-june-2021: additional surgery: procedure date: on (b)(6) 2021.Adverse event document number(s) associated with additional surgery: document number: (b)(4), document number: (b)(4), describe the additional surgical procedure: revision right total hip arthroplasty and open reduction and internal fixation of right greater trochanter fracture levels involved in additional surgical procedure: other, specify: right hip specify the relatedness of the additional surgical procedure to surgical construct and/or the study procedure: not related usade/uade assessment : no could dd have led to sade? not applicable.

• 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: 10073712
• MDR Text Key: 191532359
• Report Number: 1030489-2020-00535
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• PMA/PMN Number: P000054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: SEE-H10
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 89