InjuryKRO
JUVENILE TUMOR SYSTEM
Received Jun 25, 2026
Report 3013450937-2026-00236 · MDR key 25620060
Device
Generic name
Jts (non-invasive) Extendible Distal Femoral Replacement, Product
Manufacturer
Onkos Surgical Inc.Model number
C25-0395Lot number
C25-0395
Product problems
- Insufficient Device Problem Information
Patient
11 YR · Male
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT HAS AN ALLEGED INFECTION. THE IN-SITU DEVICE IS A JTS (NON-INVASIVE) EXTENDIBLE FEMORAL REPLACEMENT..
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.