MAUDE Adverse Event Report: OSSIO LTD. OSSIOFIBER COMPRESSION SCREW 4.0X26 MM; SCREW, FIXATION, BONE

Model Number OF1024026S

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Non-union Bone Fracture (2369); Swelling/ Edema (4577)

Event Date 11/02/2022

Event Type  Injury  

Manufacturer Narrative

Company was informed of an implant removal surgery that was performed 4 months following a navicular fracture repair.No imaging was provided.Removal surgery was performed successfully.It was noted that the removed implant was intact.The actual device could not be examined as it was not provided to the company.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 loss of compression resulting in swelling and pain which lead to the removal surgery could not be determined.Local swelling and pain are common clinical signs of unstable orthopedic fixation.Unstable fixation can be the result of numerous reasons, among them patient-related, i.E., non-compliance with post operative protocol, poor bone quality, which could not be ruled out at the time of this investigation.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.

Event Description

Removal surgery due to loss of compression, local swelling and pain 4 months following a navicular fracture repair.The single screw that was used in the procedure was removed.

• Brand Name: OSSIOFIBER COMPRESSION SCREW 4.0X26 MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OSSIO LTD.; 8 hatochen st.; caesarea, 30798 61; IS 3079861
• MDR Report Key: 16049915
• MDR Text Key: 306157775
• Report Number: 3014323288-2022-00008
• Device Sequence Number: 1
• Product Code: HWC
• 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: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2023
• Device Model Number: OF1024026S
• Device Catalogue Number: OF1024026S
• Device Lot Number: OF01506
• 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: 12/27/2022
• Distributor Facility Aware Date: 11/30/2022
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male