MAUDE Adverse Event Report: OSSIO Ltd. OSSIOfiber® Compression Staple System; ORTHOPEDIC TRAY

Model Number	OF2061110S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision about 1 year following a 4-corner fusion procedure.
Additional Manufacturer Narrative
Company was informed of a revision procedure of 2 staples.An investigation was performed including internal analysis of records.No imaging was provided.No information on clinical symptoms was shared.Revision surgery was performed successfully.Fragments of the removed implants were returned to the company and examined.There is no indication of a design, manufacturing or process issue affecting implant safety, effectiveness or sterility.Based on the limited information available the root cause leading to revision surgery could not be determined.Several known inherent risks, both procedure and patient related may lead to additional surgeries and device removals.As a revision surgery was performed and because the company cannot rule out the possible contribution of the device to the event, out of an abundance of caution, this event is being reported.Company continues to monitor these events as part of post market activities.Additional reports relating to this event are: # 3014323288-2026-00009 and 3014554088-2026-00008/9.

• Brand Name: OSSIOfiber® Compression Staple System
• Common Device Name: ORTHOPEDIC TRAY
• Manufacturer (Section D): OSSIO Ltd.; 8 hatochen st.; caesarea, 30798 61; IS 3079861
• MDR Report Key: 50782803
• Report Number: 3014323288-2026-00008
• Device Sequence Number: 9570825
• Product Code: OJH
• UDI-Device Identifier: 07290019361039
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2026
• Report Date (Section F): 09/16/2026

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: Health Professional
• Device Model Number: OF2061110S
• Device Catalogue Number: OF2061110S
• Device Lot Number: OF05101
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/19/2026
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OSSIOfiber® Compression Staple
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Date Report Sent to FDA: 09/16/2026