FDA Adverse Event
Injury
Summary report: N
BIOHORIZONS INC.
MDR report key: 18956326
·
Received March 21, 2024
Report
- Report Number
- 1060818-2024-02592
- Event Type
- Injury
- Date Received
- March 21, 2024
- Date of Event
- February 26, 2024
- Report Date
- April 23, 2024
- Manufacturer
- BIOHORIZONS INC.
- Product Code
- DZE
- UDI-DI
- 00847236010300
- PMA / PMN Number
- K223697
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
2203299.
Description of Event or Problem · 0
2203299
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2553052 | BIOHORIZONS INC. | DENTAL IMPLANT | DZE | BIOHORIZONS INC. | TMR4607 | 2203299 | 00847236010300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |