FDA Adverse Event
Injury
Summary report: N
DESS DENTAL
MDR report key: 24698378
·
Received March 26, 2026
Report
- Report Number
- 2411236-2026-00003
- Event Type
- Injury
- Date Received
- March 26, 2026
- Date of Event
- March 4, 2026
- Report Date
- March 26, 2026
- Manufacturer
- TERRATS MEDICAL S.L.
- Product Code
- NHA
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED BY A DOCTOR THAT A MALE PATIENT HAD THE ABUTMENT AND CROWN OF AN IMPLANT BREAK AT THE NECK. THERE WAS NO INJURY TO THE PATIENT BUT THE PATIENT REQUIRED THE IMPLANT TO BE REMADE AND THE PATIENT NOW HAS THAT SEATED. THE IMPLANT WAS DONE IN 2022.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 757801 | DESS DENTAL | TIBASE ENG STRBL RC 1MM | NHA | TERRATS MEDICAL S.L. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |