MAUDE Adverse Event Report: OSSIO LTD. OSSIOFIBER CANNULATED TRIMMABLE FIXATION NAIL SYSTEM; ORTHOPEDIC TRAY

Model Number	OF2053050S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	10/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant removal due to local toe swelling 2 months following a hammertoe correction procedure.Case resolved with no additional intervention.
Additional Manufacturer Narrative
Company was notified of removal procedure.Original surgery included 3 implants in the 2nd,3rd and 4th toes.The implant from the 2nd toe was removed in office 2 months following implantation, the others were removed about 2 weeks after, in the or.A product investigation was performed for all 3 devices implanted.No imaging was provided.No report of trauma.Event occurred about the time the patient was back to normal activity level.Non-compliance was not suspected.Based on internal analysis of records and procedures, there is no indication of a design, manufacturing or process issue affecting implant safety or effectiveness.The investigation, including the surgeon's feedback, concluded that this event was likely the outcome of an inappropriate implant size selection, using an implant too small for the patient bone anatomy, which resulted in an unstable implantation site.Swelling was attributed to unstable fixation of the surgical site.The instructions for use include precautions and recommendations for the selection of appropriate surgical technique, implant size, configuration, and surgical site preparation.Unstable fixation is a known inherent risk of the device and surgical procedure.Although the company does not believe that the device caused or contributed to the event, as an implant removal surgery was performed, this event is being reported out of an abundance of caution.Company continues to monitor these events as part of post market activities.Additional reports relating to this event are: # 3014554088-2025-00007/8, #3014323288-2025-00006/7/8.

• Brand Name: OSSIOFIBER CANNULATED TRIMMABLE FIXATION NAIL SYSTEM
• Common Device Name: ORTHOPEDIC TRAY
• Manufacturer (Section D): OSSIO LTD.; 8 hatochen st.; caesarea, 30798 61; IS 3079861
• Manufacturer (Section G): OSSIO LTD.; 8 hatochen st.; caesarea, 30798 61; IS 3079861
• Manufacturer Contact: taly lindner ; 8 hatochen st.; caesarea, 30798-61 ; IS 3079861
• MDR Report Key: 23677012
• Report Number: 3014554088-2025-00006
• Device Sequence Number: 15678884
• Product Code: OJH
• UDI-Device Identifier: 07290017630137
• UDI-Public: (01)07290017630137(17)270514(11)240515(10)OF04835
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2025

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 Model Number: OF2053050S
• Device Catalogue Number: OF2053050S
• Device Lot Number: OF04835
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 11/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OSSIOFIBER CANNULATED TRIMMABLE FIXATION NAIL SYS.; OSSIOFIBER CANNULATED TRIMMABLE FIXATION NAIL SYS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female