MAUDE Adverse Event Report: SPINEART SA SCARLET ALT SECURED LUMBAR ANTERIOR CAGE

Model Number	SCA-LS 15 12-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	10/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On 03.Jun.2024, we received a complaint from the field, from france, (see (b)(4) folder) reporting that the patient underwent a spine surgery on l4/l5 (not spineart device) and l5/s1 (spineart device) on (b)(6) 2021.Beginning of (b)(6) 2021, the patient had chills and abdominal pain, prevertebral fluid collection in front of l4/l5 prosthesis (prodisc-l) was discovered on (b)(6) 2021.The intensity degree of the adverse event was classified as moderate.A re-intervention was performed on (b)(6) 2021 to remove the prevertebral abscess.The outcome of the serious adverse event was reported as resolved on (b)(6) 2021.We report this case as the device involved is us marketed.
Additional Manufacturer Narrative
Investigation ongoing.
Additional Manufacturer Narrative
As per the case narrative, the patient complained about chills and abdominal pain beginning of (b)(6) 2021 and a prevertebral fluid collection in front of l4/l5 prosthesis (prodisc-l) was discovered on (b)(6) 2021.The intensity degree of the adverse event (ae) was classified as "moderate".A re-intervention was performed on (b)(6) 2021 to remove the prevertebral abscess.The outcome of the sae was reported as "resolved".The end date was (b)(6) 2021.The causal relationship of this event to the procedure was classified as "causal", and to device or instrument classified as "not related" by the reporting investigator.After we received the complaint, the manufacturing folder has been reviewed.The analysis on the manufacturing documents and control quality documents detected that raw materials and production processes were conforming to the specifications.(b)(4).Scientific literature reports (national library of medicine) that seroma is a common complication of abdominal surgeries, see postoperative seroma management - statpearls - ncbi bookshelf (nih.Gov) "seroma is the abnormal accumulation of serous fluid in a dead space containing plasma and lymphatic fluid.[1][2][3] it is a common complication of breast cancer surgery, plastic surgery, and abdominal wall hernia repair, with rates ranging between 15 to 85% following mastectomy and a global prevalence of 10.9% following abdominoplasty.[4][5][6] surgical procedures with extensive soft tissue dissection are more likely to transect blood and lymphatic vessels and lead to a transudative fluid collection.Cases that have undergone significant resection of tissue result in a large potential dead space, making it more difficult for flaps to adhere and creating shearing forces between tissue surfaces.This is thought to contribute to an inflammatory process with exudative fluid from tissues adding to seroma formation".Plus, seroma is part of the general adverse events listed in the clinical evaluation report (cer) (b)(4).Based on the above information, we confirm that the issue reported is not linked to the device implanted but that it is related to the procedure.Since the launch of the device, (b)(4).We close the case as is with no further action.
Event or Problem Description
On 03.Jun.2024, we received a complaint from the field, from (b)(6) , (see (b)(4) folder) reporting that the patient underwent a spine surgery on l4/l5 (not spineart device) and l5/s1 (spineart device) on (b)(6) 2021.Beginning of (b)(6) 2021, the patient had chills and abdominal pain, prevertebral fluid collection in front of l4/l5 prosthesis (prodisc-l) was discovered on (b)(6) 2021.The intensity degree of the adverse event was classified as moderate.A re-intervention was performed on (b)(6) 2021 to remove the prevertebral abscess.The outcome of the serious adverse event was reported as resolved on (b)(6) 2021.We report this case as the device involved is us marketed.

• Brand Name: SCARLET ALT SECURED LUMBAR ANTERIOR CAGE
• Common Device Name: SCARLET ALT SECURED LUMBAR ANTERIOR CAGE
• Manufacturer (Section D): SPINEART SA; chemin du pré fleuri 3; plan-les-ouates, geneva 1228 ; SZ 1228
• Manufacturer Contact: laure-allison verboux ; chemin du pré fleuri 3; plan-les-ouates, geneva 1228 ; SZ 1228
• MDR Report Key: 19594088
• Report Number: 3007728266-2024-00008
• Device Sequence Number: 11802220
• Product Code: OVD
• UDI-Device Identifier: 07640178988057
• UDI-Public: (01)07640178988057
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: SCA-LS 15 12-S
• Device Catalogue Number: SCA-LS 15 12-S
• Device Lot Number: 5-0628
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female