FDA Adverse Event
Injury
Summary report: N
ACE BLT RP IMPLANT 4.1X10MM
MDR report key: 11736632
·
Received April 28, 2021
Report
- Report Number
- 8010516-2021-00016
- Event Type
- Injury
- Date Received
- April 28, 2021
- Date of Event
- October 7, 2020
- Report Date
- April 27, 2021
- Manufacturer
- HAGER & MEISINGER GMBH
- Product Code
- DZE
- UDI-DI
- E0HM240021
- PMA / PMN Number
- K170287
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION NOT POSSIBLE DUE TO A PRODUCT THAT WAS NOT PRODUCED BY THE COMPANY.
Description of Event or Problem · 1
SURGEON NEEDED A LONGER IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 633173 | ACE BLT RP IMPLANT 4.1X10MM | DENTAL IMPLANT | DZE | HAGER & MEISINGER GMBH | 3624002DU0ACE | B82816 | E0HM240021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other |