MAUDE Adverse Event Report: ONKOS SURGICAL INC. ELEOS¿ LIMB SALVAGE SYSTEM; ELEOS¿ DISTAL FEMUR LEFT, SEGMENTAL 65MM

Catalog Number	25000007E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause of this complaint was not determined.Based on the review of device history records, the lot was fond to be conforming to specifications.If more information is reported, a supplemental mdr will be updated.
Event or Problem Description
It was reported by an onkos sales representative, that a patient with eleos distal femur replacement underwent revision surgery on (b)(6) 2025 due to unknown reasons.This report captures eleos distal femur.This event will be reported as a serious injury due to the revision procedure.

• Brand Name: ELEOS¿ LIMB SALVAGE SYSTEM
• Common Device Name: ELEOS¿ DISTAL FEMUR LEFT, SEGMENTAL 65MM
• Manufacturer (Section D): ONKOS SURGICAL INC.; 77 e halsey road; parsippany 07054
• Manufacturer Contact: yara neurauter ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 24089134
• Report Number: 3013450937-2026-00036
• Device Sequence Number: 20281089
• Product Code: KRO
• UDI-Device Identifier: B27825000007E0
• UDI-Public: B27825000007E0
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 01/15/2026

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 Catalogue Number: 25000007E
• Device Lot Number: 1897221
• 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: 12/19/2025
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 57 YR
• Patient Sex: Female