MAUDE Adverse Event Report: OSSIO LTD. OSSIOFIBER COMPRESSION STAPLE SYSTEM; ORTHOPEDIC TRAY

Model Number	OF2060910S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Loss of fracture reduction (4901)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Company was notified of a removal surgery several months following akin osteotomy in the proximal phalanx of the great toe, due to implant backing out.Instability at the site was also noted.No imaging was provided.The actual device could not be examined as it was not provided to the company.Patient also had 1st tmt joint fusion procedure done during the original surgery which healed uneventfully.No report of trauma.Non-compliance was not suspected.A product investigation was performed for this device.Based on internal analysis of records, procedures, and surgeon's feedback there is no indication of a design, manufacturing or process issue affecting implant safety or effectiveness.Based on the information available the root cause of the event could not be determined.Unstable fixation can be the result of numerous reasons and is a known inherent risk of the device and surgical procedure.However, as a removal 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 report from the initial importer relating to this event is: #3014323288-2025-00002.
Event or Problem Description
Removal surgery several months following akin osteotomy in the proximal phalanx of the great toe, due to implant backing out.

• Brand Name: OSSIOFIBER COMPRESSION STAPLE 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: 22053618
• Report Number: 3014554088-2025-00002
• Device Sequence Number: 5192385
• Product Code: OJH
• UDI-Device Identifier: 07290017630670
• UDI-Public: (01)07290017630670(17)270204(11)240205(10)OF04769
• 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: 2024
• 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): 05/20/2025

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: OF2060910S
• Device Catalogue Number: OF2060910S
• Device Lot Number: OF04769
• 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: 04/23/2025
• Initial Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2024
• 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 COMPRESSION SCREW 4.0X40 MM; OSSIOFIBER COMPRESSION STAPLE SYSTEM 15 X 15 MM; OSSIOFIBER COMPRESSION STAPLE SYSTEM 20 X 20 MM; OSSIOFIBER HAMMERTOE FIXATION SYSTEM 2.9X19MM, STR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR
• Patient Sex: Female