FDA Adverse Event
Injury
Summary report: N
INFINITY OCTAGON
MDR report key: 22737242
·
Received August 7, 2025
Report
- Report Number
- 1287163-2025-02402
- Event Type
- Injury
- Date Received
- August 7, 2025
- Date of Event
- June 30, 2025
- Report Date
- August 7, 2025
- Manufacturer
- HAGER & MEISINGER GMH
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- MA, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
FAILURE TO OSEOINTEGRATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2006328 | INFINITY OCTAGON | DENTAL IMPLANT | DZE | HAGER & MEISINGER GMH | 504810BL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male | Required Intervention |