MAUDE Adverse Event Report: OSSIO LTD. OSSIOFIBER HAMMERTOE FIXATION SYSTEM; PIN, FIXATION, SMOOTH

Catalog Number	OF20025160
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision procedure about 1 month following hammertoe fixation surgery due to local inflammatory reaction in a patient with rheumatoid arthritis.
Additional Manufacturer Narrative
Company was notified of a revision surgery.An investigation was performed based on the information provided by the surgeon and production records.Surgeon reported that a patient who has rheumatoid arthritis (pre-existing auto-immune disorder), had what appears as a local inflammatory reaction, which led to replacement of the implant with a k-wire.Patient was reported to have healed following the revision.The device could not be examined as it was not provided.No imaging or test results were provided.There is no indication of a design, manufacturing or process issue affecting implant safety or effectiveness.Implantation in patients with autoimmune disorders is not specifically contraindicated, nevertheless, company cannot rule out in advance an inflammatory reaction in face of autoimmune conditions.The implant instructions for use recommends precaution and evaluation of each situation individually based on the patient's history, clinical presentation, and concomitant medications use.It also lists an inflammatory or allergic reaction as a potential adverse effect to implantation of foreign material.Inflammatory reaction can be the result of numerous reasons and is a known inherent risk of the device and surgical procedure.The investigation concluded that the root cause is likely the outcome of the patient experiencing a local reaction due to pre-existing condition, though other causes could not be ruled out.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 report from the manufacturer relating to this event is: #.

• Brand Name: OSSIOFIBER HAMMERTOE FIXATION SYSTEM
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): OSSIO LTD.; 8 hatochen st.; caesarea, 30798 61; IS 3079861
• MDR Report Key: 23346200
• Report Number: 3014323288-2025-00005
• Device Sequence Number: 13147667
• Product Code: HTY
• UDI-Device Identifier: 07290017630076
• UDI-Public: (01)07290017630076(17)260730(11)240731(10)OF04885
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2025
• Report Date (Section F): 10/21/2025

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 Expiration Date: 07/30/2026
• Device Catalogue Number: OF20025160
• Device Lot Number: OF04885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/23/2025
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2025
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Date Report Sent to FDA: 10/21/2025