FDA Adverse Event
Injury
Summary report: N
JDEVOLUTION PLUS
MDR report key: 22727953
·
Received August 6, 2025
Report
- Report Number
- 3013264549-2023-00103
- Event Type
- Injury
- Date Received
- August 6, 2025
- Report Date
- December 28, 2023
- 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 02-18-22-10822 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 OF OSSEOINTEGRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1765219 | JDEVOLUTION PLUS | JDEVOLUTION PLUS Ø 4.3 L 13 | DZE | J DENTAL CARE SRL | 02-18-22-10822 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |