MAUDE Adverse Event Report: ONKOS SURGICAL INC. ELEOS¿ LIMB SALVAGE SYSTEM; ELEOS¿ MALE-MALE MIDSECTION 70MM

Catalog Number	MS-070MM-02M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.An investigation of the device history record and post-market surveillance history was completed and nothing was found.If additional information is obtained or if the device is returned, a supplemental mdr will be submitted accordingly.
Event or Problem Description
It was reported by an onkos sales representative, that a patient with eleos proximal femur replacement underwent revision surgery on (b)(6) 2025 due to an alleged dislocation.Surgeon shortened eleos male-male midsection from 70mm to 40mm.This report captures eleos male-male midsection.This event will be reported as a serious injury due to the revision procedure.

• Brand Name: ELEOS¿ LIMB SALVAGE SYSTEM
• Common Device Name: ELEOS¿ MALE-MALE MIDSECTION 70MM
• 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: 25620506
• Report Number: 3013450937-2026-00237
• Device Sequence Number: 9101813
• Product Code: KRO
• UDI-Device Identifier: B278MS070MM02M0
• UDI-Public: B278MS070MM02M0
• 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: 2026
• Device Explanted Year: 2026
• 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): 06/25/2026

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: MS-070MM-02M
• Device Lot Number: P230691-001
• 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: 05/26/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2024
• 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: 21 YR
• Patient Sex: Male