FDA Adverse Event
Injury
Summary report: N
TISSUE LEVEL DENTAL IMPLANT RP Ø4.1 L10
MDR report key: 19545376
·
Received June 17, 2024
Report
- Report Number
- 8010516-2024-00067
- Event Type
- Injury
- Date Received
- June 17, 2024
- Date of Event
- January 10, 2024
- Report Date
- June 17, 2024
- Manufacturer
- HAGER & MEISINGER GMBH
- Product Code
- DZE
- UDI-DI
- E0HM5041101
- PMA / PMN Number
- K122807
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
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 · 0
MISSING OSSEOINTEGRATION, SAME PATIENT AS 8010516-2024-00066.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1009622 | TISSUE LEVEL DENTAL IMPLANT RP Ø4.1 L10 | DENTAL IMPLANT | DZE | HAGER & MEISINGER GMBH | 3631152DU0ACE | C10383 | E0HM5041101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Male | Other |