FDA Adverse Event
Injury
Summary report: N
JDEVOLUTION PLUS
MDR report key: 22307240
·
Received June 23, 2025
Report
- Report Number
- 3013264549-2025-00022
- Event Type
- Injury
- Date Received
- June 23, 2025
- Date of Event
- April 2, 2025
- Report Date
- April 30, 2025
- Manufacturer
- J DENTAL CARE SRL
- Product Code
- DZE
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE DHR FOR LOT 01-41-24-2525 WAS REVIEWED, AND NO EVIDENCE OF DEFECTS OR NON-CONFORMITIES WAS IDENTIFIED FOR THE PRODUCT UNDER COMPLAINT. THE RESULTS OF THE INVESTIGATION CONFIRM THAT BOTH THE MANUFACTURING AND STERILIZATION PROCESSES ARE IN COMPLIANCE. QUALITY CONTROL PROCEDURES ENSURE THAT BATCHES MEET THE NECESSARY SPECIFICATIONS BEFORE DISTRIBUTION.
Description of Event or Problem · 0
LACK OF PRIMARY STABILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 926627 | JDEVOLUTION PLUS | JDEVOLUTION PLUS Ø 3.7 L 11.5 | DZE | J DENTAL CARE SRL | 01-41-24-2525 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Female |