FDA Adverse Event
Injury
Summary report: N
JUVENILE TUMOR SYSTEM (JTS)
MDR report key: 20864489
·
Received December 6, 2024
Report
- Report Number
- 3013450937-2024-00402
- Event Type
- Injury
- Date Received
- December 6, 2024
- Report Date
- December 6, 2024
- Manufacturer
- ONKOS SURGICAL
- Product Code
- KRO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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
IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED FOR THE IN-SITU JTS (NON-INVASIVE) EXTENDIBLE DISTAL FEMORAL REPLACEMENT (CASE # PIN 21847). A SHORT TIBIAL CASED TIBIAL COMPONENT WAS PROVIDED UNDER (CASE # C24-0703) IN NOVEMBER 2024 FOR AN UPCOMING SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2515923 | JUVENILE TUMOR SYSTEM (JTS) | JTS (NON-INVASIVE) EXTENDIBLE DISTAL FEMORAL REPLACEMENT | KRO | ONKOS SURGICAL | PIN 21847 | PIN 21847 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization |