MAUDE Adverse Event Report: OSSIO LTD. OSSIOFIBER COMPRESSION SCREW 3.5X22MM; SCREW, FIXATION, BONE

Model Number	OF1073522S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Local Reaction (2035)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Pain and localized bone edema in the left foot following a bunion deformity correction.Four implants were removed one year post-op.
Additional Manufacturer Narrative
Company was notified of a scheduled removal surgery following localized pain in the operated left foot a year after implantation.The removal surgery was completed successfully.An investigation was performed including internal analysis of records, patient imaging, lab work and surgeon feedback.There is no indication of a design, manufacturing, sterilization, or process issue affecting implant safety or effectiveness.There were no issues during the primary procedure.Patient post op recovery was uneventful, and bone healing and fusion of the operated sites was achieved.Imaging due to the reported pain revealed localized bone edema.Infection was ruled out by the lab work, negative culture, and timing of symptoms.The investigation concluded that the root cause of the pain could not be determined but is likely the outcome of the patient experiencing a local reaction to one of the implant's materials or related to an unreported underlying medical condition.Instructions for use list an allergic reaction as a potential adverse effect to implantation of foreign material.Company continues to monitor these events as part of post market activities.Additional reports relating to this event: # 3014554088-2024-00003/4/6 & 3014323288-2024-00003/4/5/6.

• Brand Name: OSSIOFIBER COMPRESSION SCREW 3.5X22MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: 19173134
• Report Number: 3014554088-2024-00005
• Device Sequence Number: 7456257
• Product Code: HWC
• UDI-Device Identifier: 07290017630762
• UDI-Public: (01)07290017630762(17)240814(11)220815(10)OF02580
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K213596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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): 04/24/2024

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: 08/14/2024
• Device Model Number: OF1073522S
• Device Catalogue Number: OF1073522S
• Device Lot Number: OF02580
• 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: 03/27/2024
• Initial Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2022
• 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 3.5X24MM; OSSIOFIBER COMPRESSION SCREW 4.0X38MM; OSSIOFIBER COMPRESSION STAPLE SYSTEM 20X20MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 19 YR
• Patient Sex: Female