FDA Adverse Event
Injury
Summary report: N
TISSUE LEVEL DENTAL IMPLANT RP Ø3.3 L10
MDR report key: 17825376
·
Received September 27, 2023
Report
- Report Number
- 8010516-2023-00088
- Event Type
- Injury
- Date Received
- September 27, 2023
- Date of Event
- May 23, 2023
- Report Date
- September 27, 2023
- Manufacturer
- HAGER & MEISINGER GMBH
- Product Code
- DZE
- UDI-DI
- E0HM5033101
- 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. SAME PATIENT AS FOR CASE 8010516-2023-000890.
Description of Event or Problem · 0
MISSING OSSEOINTEGRATION, SAME PATIENT AS FOR CASE 8010516-2023-00089.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 985656 | TISSUE LEVEL DENTAL IMPLANT RP Ø3.3 L10 | DENTAL IMPLANT | DZE | HAGER & MEISINGER GMBH | 3672187DU0ACE | C09863 | E0HM5033101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Male | Other |