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

Model Number P1603LII

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

Patient Problems Pain (1994); Stenosis (2263); Numbness (2415)

Event Date 06/16/2020

Event Type  Injury  

Manufacturer Narrative

The following products have been used in the surgery: part#: p1603lii; lot#: m111501aaf; pma#: p000058; udi#: (b)(4), qty#: 2.Part#: 5540030; lot#: h5406110 ; 510k#: k113174; udi#: (b)(4), qty# 8.Part#: 4011022; lot#: 46ak; 510k#: k120368; udi#: (b)(4), qty#: 1.Part#: p1603mgs; lot#: cccn16l4; 510k#: k082166; udi#: (b)(4), qty#: 2.Part#: 1553201080; lot#: 0514330w; 510k#: k113174; udi#: (b)(4) qty#: 1.Part#: 55410007545; lot#: 0217237w; 510k#: k113174; udi#: (b)(4), qty#: 4.Part#: 55840007545; lot#: h5282748; 510k#: k113174; udi#: (b)(4), qty#: 2.Part#: 55840006545; lot#: 0617572w; 510k#: k113174; udi#: (b)(4), 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

Information received from a post market clinical study- (infuse plf) infuse bone graft with mastergraft strip for (plf).Patient medical history: currently consume alcohol.Pre-operative diagnostics: stenosis with documented pre_operative instability, recurrent disc herniation, concomitant lumbar degenerative deformity (cobb angle < or equal to 30 degrees) from l2- s1.Patient had acute epidural hematoma surgery: surgeon identified compressive hematoma at l3-l4 and l4-l5 levels and was able to clear out around the l4 nerve root and ensure that it was fully free, also 3/12 positive for adenocarcinoma; the left mid lateral and left medial showed gleason 4+4=8 prostate cancer and the right base medial showed gleason 3+3=6 prostate cancer.It was reported that post-operative patient had neuroforaminal stenosis noted at l5-s1 on lumbar ct scan.Action subtype: lumbar ct scan-1 action result: abnormal action info: diagnostic tests performed: foraminal stenosis at l5- s1.Site relatedness assessment: this event was not related to any devices and surgical procedure used.Sponsor relatedness assessment: this event was possibly related with the infuse kit, mgs kit, interbody device, multiaxial screws, rods, set screws and not related to the procedure and surgical procedure used.Treatment group: group 2 - infuse 6 + mastergraft + local bone implant date: (b)(6) 2018 seriousness assessment: non-serious patient came for follow up visit on (b)(6) 2018.Patient came for follow up visit on (b)(6) 2018.Patient came for follow up visit on (b)(6) 2018.Patient came for follow up visit on (b)(6) 2019.Patient came for follow up visit on (b)(6) 2020.

Event Description

Information received from a post market clinical study- (infuse plf) infuse bone graft with mastergraft strip for (plf).Patient medical history: currently consume alcohol.Pre-operative diagnostics: stenosis with documented pre_operative instability, recurrent disc herniation, concomitant lumbar degenerative deformity (cobb angleor equal to 30 degrees) from l2- s1.Patient had acute epidural hematoma surgery: surgeon identified compressive hematoma at l3-l4 and l4-l5 levels and was able to clear out around the l4 nerve root and ensure that it was fully free, also 3/12 positive for adenocarcinoma; the left mid lateral and left medial showed gleason 4+4=8 prostate cancer and the right base medial showed gleason 3+3=6 prostate cancer.It was reported that post-operative patient had neuroforaminal stenosis noted at l5-s1 on lumbar ct scan.Action subtype: lumbar ct scan-1 action result: abnormal action info: diagnostic tests performed: foraminal stenosis at l5- s1.Site relatedness assessment: this event was not related to any devices and surgical procedure used.Sponsor relatedness assessment: this event was possibly related with the infuse kit, mgs kit, interbody device, multiaxial screws, rods, set screws and not related to the procedure and surgical procedure used.Treatment group: group 2 - infuse 6 + mastergraft + local bone implant date: (b)(6) 2018 seriousness assessment: non-serious patient came for follow up visit on (b)(6) 2018.Patient came for follow up visit on (b)(6) 2018.Patient came for follow up visit on (b)(6) 2018.Patient came for follow up visit on (b)(6) 2019.Patient came for follow up visit on (b)(6) 2020.Updated information received on 2020 sep 10: neuroforaminal stenosis noted at l5-s1 on lumbar ct scan.Subject also complains of right foot numbness and left foot dysesthesia secondary to stenosis at l5-s1.

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.

• 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: 10394453
• MDR Text Key: 202934659
• Report Number: 1030489-2020-01067
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2019
• Device Model Number: P1603LII
• Device Catalogue Number: P1603LII
• Device Lot Number: M111501AAF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 98