FDA Adverse Event
Injury
Summary report: N
JDICON PLUS
MDR report key: 23768093
·
Received December 10, 2025
Report
- Report Number
- 3013264549-2025-00097
- Event Type
- Injury
- Date Received
- December 10, 2025
- Date of Event
- October 27, 2025
- Report Date
- November 10, 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 01-27-24-2725 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 TO OSSEOINTEGRATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2878246 | JDICON PLUS | JDICON PLUS Ø 4.3 L 15 | DZE | J DENTAL CARE SRL | 01-27-24-2725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Female |