FDA Adverse Event
Injury
Summary report: N
ACE BL RP IMPLANT 4.1X10MM
MDR report key: 11918993
·
Received June 2, 2021
Report
- Report Number
- 8010516-2021-00031
- Event Type
- Injury
- Date Received
- June 2, 2021
- Date of Event
- March 1, 2021
- Report Date
- June 1, 2021
- Manufacturer
- HAGER & MEISINGER GMBH
- Product Code
- DZE
- UDI-DI
- E0HM22002DU0ACE1
- PMA / PMN Number
- K143539
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION OF THE COMPLAINT WAS CARRIED OUT CONSIDERING THE ANALYSIS OF THE INFORMATION GIVEN BY THE DENTIST IN THE GUARANTEE FORM, VISUAL CONFERENCE OF THE PRODUCT RETURNED BY THE DENTIST AND THE EVALUATION OF RELEVANT PRODUCTION RECORDS.
Description of Event or Problem · 1
PRIMARY STABILITY WAS NOT ACHIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 817190 | ACE BL RP IMPLANT 4.1X10MM | DENTAL IMPLANT | DZE | HAGER & MEISINGER GMBH | 3622002DU0ACE | B50627 | E0HM22002DU0ACE1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Other |