FDA Adverse Event
Injury
Summary report: N
JDEVOLUTION PLUS
MDR report key: 23038389
·
Received September 12, 2025
Report
- Report Number
- 3013264549-2025-00061
- Event Type
- Injury
- Date Received
- September 12, 2025
- Date of Event
- February 15, 2025
- Report Date
- September 1, 2025
- Manufacturer
- J DENTAL CARE SRL
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE DHR FOR LOT 01-43-23-2124 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
FAILURE DUE TO LACK OF OSSEOINTEGRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1975015 | JDEVOLUTION PLUS | JDEVOLUTION PLUS Ø 3.7 L 13 | DZE | J DENTAL CARE SRL | 01-43-23-2124 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |