FDA Adverse Event
Injury
Summary report: N
JDICON PLUS
MDR report key: 24262306
·
Received February 4, 2026
Report
- Report Number
- 3013264549-2026-00004
- Event Type
- Injury
- Date Received
- February 4, 2026
- Date of Event
- December 10, 2025
- Report Date
- January 9, 2026
- 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 01-27-24-2525 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
LOSS OF OSTEOINTEGRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321165 | JDICON PLUS | JDICON PLUS Ø 4.3 L 10 | DZE | J DENTAL CARE SRL | 01-27-24-2525 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Male |