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

Catalog Number SEE H10

Device Problem Failure to Osseointegrate (1863)

Patient Problem Inadequate Osseointegration (2646)

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 consumes 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.Date of diagnosis as related to subjects cancer: (b)(6) 2020 date of pathology report: (b)(6) 2020 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 gleason 3+3=6 prostate cancer.Location / type of cancer: prostate cancer records pending 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, it was reported that post-operative patient had : possible non-union noted at l2-3 on lumbar ct scan.Diagnostics action type: diagnostic action subtype: lumbar ct scan-1 action result: abnormal action date: (b)(6) 2020 action info: diagnostic tests performed: possible non-union at l2-3 interventions action subtype: other action result: y- additional surgery recommended action subtype: other relevant actions action result: y outcome status : pending 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.

• 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
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10394448
• MDR Text Key: 202507782
• Report Number: 1030489-2020-01066
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2019
• Device Catalogue Number: SEE H10
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 98