MAUDE Adverse Event Report: ONKOS SURGICAL INC. ELEOS¿ LIMB SALVAGE SYSTEM; ELEOS¿ TIBIAL POLY SPACER 8MM

Catalog Number	25001208E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
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 an alleged infection.No prior post bill was found of unknown patient.The devices will be reported with unknown lot numbers.This report captures eleos poly spacer.This event will be reported as a serious injury due to the revision procedure.
Additional Manufacturer Narrative
The root cause of this complaint was not determined due to insufficient information of the unknown device explanted.If more information is attained, a supplemental report will be updated.

• Brand Name: ELEOS¿ LIMB SALVAGE SYSTEM
• Common Device Name: ELEOS¿ TIBIAL POLY SPACER 8MM
• 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: 24069084
• Report Number: 3013450937-2026-00028
• Device Sequence Number: 18712712
• Product Code: KRO
• UDI-Device Identifier: B27825001208E0
• UDI-Public: B27825001208E0
• 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 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): 01/14/2026

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: 25001208E
• 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: 12/18/2025
• Initial Report FDA Received Date: 01/14/2026
• 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 Sex: Unknown