FDA Adverse Event
Injury
Summary report: N
BIOHORIZONS INC.
MDR report key: 23568549
·
Received November 17, 2025
Report
- Report Number
- 1060818-2025-36038
- Event Type
- Injury
- Date Received
- November 17, 2025
- Date of Event
- February 13, 2025
- Report Date
- November 18, 2025
- Manufacturer
- BIOHORIZONS INC.
- Product Code
- DZE
- UDI-DI
- 00847236013769
- PMA / PMN Number
- K223697
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE REVIEW OF THE COMPLAINT DATA REVEALED INCORRECT PRODUCT WAS REPORTED BY THE CUSTOMER THAT WOULD HAVE BEEN SUBMITTED UNDER THE VSMR REPORT AND NOT INDIVIDUAL REPORTED. THE RETURNING PRODUCT HAS A DZE PROCODE.
Description of Event or Problem · 0
IMPLANT FAILED TO OSSEOINTEGRATE.
Description of Event or Problem · 0
IMPLANT FAILED TO OSSEOINTEGRATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2874205 | BIOHORIZONS INC. | DENTAL IMPLANT | DZE | BIOHORIZONS INC. | BTA4610 | 2205112 | 00847236013769 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |