FDA Adverse Event
Injury
Summary report: N
JUVENILE TUMOR SYSTEM (JTS)
MDR report key: 22790565
·
Received August 12, 2025
Report
- Report Number
- 3013450937-2025-00160
- Event Type
- Injury
- Date Received
- August 12, 2025
- Report Date
- August 12, 2025
- Manufacturer
- ONKOS SURGICAL
- Product Code
- KRO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
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.
Description of Event or Problem · 0
DURING THE SURGERY FOR C25-0194, IT WAS IDENTIFIED THAT THE IN-SITU DEVICE (PIN 21271) INNER SHAFT WAS FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 763664 | JUVENILE TUMOR SYSTEM (JTS) | JTS EXTENDIBLE DISTAL FEMORAL REPLACEMENT | KRO | ONKOS SURGICAL | PIN 21271 | PIN 21271 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Hospitalization |