MAUDE Adverse Event Report: ONKOS SURGICAL INC ELEOS LIMB SALVAGE SYSTEM; STEM EXTENSION

Catalog Number	KSC01530E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient had an alleged infection.The patient was implanted with an onkos distal femoral replacement on (b)(6) 2024.The patient underwent a procedure to remove all hardware and elected to undergo an amputation on (b)(6) 2024.All manufacturing records of implanted devices were reviewed and no manufacturing abnormalities were observed.As detailed in the eleos limb salvage system ifu and surgical technique documentation, elements such as patient contraindications, patient selection factors, surgical procedures/techniques and other precautions/conditions may contribute to adverse effects.The root cause of this event was not determined.Based on the review of known device history records, the investigation concluded that the root cause of the alleged infection was not likely related to the design, manufacture, and/or sterilization of the onkos implants.
Event or Problem Description
It was reported that the patient implanted with an onkos distal femoral replacement had an alleged infection.The patient's index procedure occured on (b)(6) 2024.The patient underwent a procedure to remove all hardware and elected to undergo an amputation on (b)(6) 2024.This event will be reportable to the fda due to the revision procedure.This report captures the explanted eleos stem extension.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: STEM EXTENSION
• Manufacturer (Section D): ONKOS SURGICAL INC; 77 e halsey rd; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 20338744
• Report Number: 3013450937-2024-00311
• Device Sequence Number: 15467078
• Product Code: KRO
• UDI-Device Identifier: B278KSC01530E0
• UDI-Public: B278KSC01530E0
• 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: 2024
• Device Explanted Year: 2024
• 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): 09/30/2024

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: KSC01530E
• Device Lot Number: 1954352
• 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: 09/12/2024
• Initial Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/30/2022
• 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: 76 YR
• Patient Sex: Female