MAUDE Adverse Event Report: S.B.M. SAS ComposiTCP; Fastener, Fixation, Biodegradable, Soft Tissue

Catalog Number	110026109
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury

• Brand Name: ComposiTCP
• Common Device Name: Fastener, Fixation, Biodegradable, Soft Tissue
• Manufacturer (Section D): S.B.M. SAS; zi du monge; lourdes 65100 ; FR 65100
• MDR Report Key: 50833705
• Report Number: 0001825034-2026-02803
• Device Sequence Number: 10248064
• Product Code: MAI
• UDI-Device Identifier: 03760154008259
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K180960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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 Catalogue Number: 110026109
• Device Lot Number: 243434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/19/2026