MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; TIBIAL POLY SPACER

Lot Number	1940068
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	08/09/2024
Type of Reportable Event	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 alleged infection was not related to the design, manufacture, and/or sterilization of the revised eleos implants.
Event or Problem Description
It was reported by b.Matsen, an onkos sales representative, that a 16-year-old female patient with an eleos distal femur replacement underwent revision surgery on (b)(6) 2024 due to a possible infection which is believed to be preventing the patient's wound from healing.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: TIBIAL POLY SPACER
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer Contact: yara neurauter ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 20025912
• Report Number: 3013450937-2024-00270
• Device Sequence Number: 7364123
• Product Code: KRO
• UDI-Device Identifier: B27825001212E0
• UDI-Public: B27825001212E0
• 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): 08/16/2024

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 Lot Number: 1940068
• 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: 08/13/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DISTAL FEMUR AXIAL PIN.; DISTAL FEMUR.; MALE-FEMALE MIDSECTION 50MM.; MALE-FEMALE MIDSECTION 70MM.; TIBIAL POLY SPACER.; TIBIAL ROTATIONAL HINGE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR
• Patient Sex: Female