MAUDE Adverse Event Report: ONKOS SURGICAL INC. ELEOS¿ LIMB SALVAGE SYSTEM; ELEOS¿ STEM EXTENSION14X100MM STRAIGHT, SPLINED, SLOTTED 14X100MM

Catalog Number	KSP13100E
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	03/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It has been reported by an onkos sales representative that a patient with eleos proximal tibial replacement revision date on (b)(6) 2026.Reprted that femur was revised due to patellar tracking in addition to aseptic loosening of the femoral component.This report captures eleos stem extension as serious injury.
Additional Manufacturer Narrative
The root cause of this complaint was not determined.Based on the review of known device history records, the investigation concluded that the root cause of the reported loosening was not related to the design, manufacture, and/or sterilization of the revised eleos implants.Note: this is a supplemental report to (b)(4).Mdr# 3013450937-2026-00105.

• Brand Name: ELEOS¿ LIMB SALVAGE SYSTEM
• Common Device Name: ELEOS¿ STEM EXTENSION14X100MM STRAIGHT, SPLINED, SLOTTED 14X100MM
• 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: 24663385
• Report Number: 3013450937-2026-00139
• Device Sequence Number: 20097468
• Product Code: KRO
• UDI-Device Identifier: B278KSP13100E0
• UDI-Public: B278KSP13100E0
• 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: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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 Expiration Date: 04/10/2026
• Device Catalogue Number: KSP13100E
• Device Lot Number: 1732166
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2018
• 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: 16 YR
• Patient Sex: Male