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

Model Number	SCA-LM 20 16-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, we received an updated complaint from the field, from clinical studies, (b)(4) reporting that, following a surgery realized on (b)(6) 2023 (alif - l5s1 - (b)(6), - alif - l4l5 - (b)(6), tdr - l3l4 - prodisc l), the patient suffered from an abdominal wall eventration which started on (b)(6) 2024 (around 3 months po) and was considered as an ade as per site and sponsor assessment (relationship to procedure) with moderate severity.A re-intervention was decided, and a parietal repair surgery was realized on (b)(6) 2024.The event was classified as resolved on (b)(6) 2024.As per site, the event is not related to study device or to a "device" instrument, but possibly related to the procedure.This ae is not associated with a device deficiency.We report this case because a device marketed in the us in involved.
Additional Manufacturer Narrative
After reception of the complaint, the manufacturing folder has been reviewed.It is confirmed that the raw materials and production processes are conform to the predefined specifications.There have been no non-conformities observed during the manufacturing process.Complained device belongs to a batch of (b)(4) units, manufactured in (b)(6) 2022.This is the 1st complaint we received for this batch.Scientific literature reports that ventral hernia (similar to eventration) is a common complication of abdominal surgeries (see "nho" and "caro" articles - cpt folder).Based on the above information, we conclude 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) cages (b)(6) have been implanted and this is the 7th complaint we receive for this kind of issue, which represents (b)(4) of issue, the rate is very low.We close the case as is with no further action.

• Brand Name: SCARLET ALT SECURED LUMBAR ANTERIOR CAGE - HYPERLORDOTIC
• Common Device Name: SCARLET ALT SECURED LUMBAR ANTERIOR CAGE - HYPERLORDOTIC
• 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: 20843059
• Report Number: 3007728266-2024-00017
• Device Sequence Number: 14385137
• Product Code: OVD
• UDI-Device Identifier: 07640185342071
• UDI-Public: 07640185342071
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: SCA-LM 20 16-S
• Device Lot Number: 6-5438
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Age: 62 YR
• Patient Sex: Female