MAUDE Adverse Event Report: OSSIO LTD. OSSIOFIBER COMPRESSION STAPLE SYSTEM 20X20MM; STAPLE, ABSORBABLE

Model Number OF2062020S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Local Reaction (2035)

Event Date 03/26/2024

Event Type  Injury  

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: # 3014554088-2024-00003/4/5/6 & 3014323288-2024-00003/4/5.

Event Description

Pain and localized bone edema in the left foot following a bunion deformity correction.Four implants were removed one year post-op.

• Brand Name: OSSIOFIBER COMPRESSION STAPLE SYSTEM 20X20MM
• Type of Device: STAPLE, ABSORBABLE
• Manufacturer (Section D): OSSIO LTD.; 8 hatochen st.; caesarea, 30798 61; IS 3079861
• MDR Report Key: 19173193
• MDR Text Key: 340931902
• Report Number: 3014323288-2024-00006
• Device Sequence Number: 1
• Product Code: MNU
• UDI-Device Identifier: 07290017630700
• UDI-Public: (01)07290017630700(17)240416(11)221218(10)OF02229
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2024
• Device Model Number: OF2062020S
• Device Catalogue Number: OF2062020S
• Device Lot Number: OF02229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2024
• Distributor Facility Aware Date: 03/27/2024
• Device Age: 3 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 03/27/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OSSIOFIBER COMPRESSION SCREW 3.5X22MM; OSSIOFIBER COMPRESSION SCREW 3.5X24MM; OSSIOFIBER COMPRESSION SCREW 4.0X38MM
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR
• Patient Sex: Female