MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; CANAL FILLING STEM

Lot Number	92364-009
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Fall (1848); Limb Fracture (4518)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The probable root cause of the reported incident has been determined to be low bone density combined with a traumatic fall.
Event or Problem Description
An onkos sales representative reported that a 63-year-old female patient with an eleos proximal femur replacement underwent revision surgery due to a peri-prosthetic fracture of the distal femur.The bone fracture reportedly occurred after the patient fell.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: CANAL FILLING STEM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer Contact: yara neurauter ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 22030975
• Report Number: 3013450937-2025-00106
• Device Sequence Number: 8123345
• Product Code: KRO
• UDI-Device Identifier: B278FS1212003M0
• UDI-Public: B278FS1212003M0
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2025

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
• Device Lot Number: 92364-009
• 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: Not provided
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female