FDA Adverse Event
Injury
Summary report: N
ELEMENT IMPLANT, PF 4,5, E 4,2, L 11,0
MDR report key: 7941285
·
Received October 6, 2018
Report
- Report Number
- 3003184527-2018-01031
- Event Type
- Injury
- Date Received
- October 6, 2018
- Date of Event
- June 11, 2018
- Report Date
- June 15, 2018
- Manufacturer
- THOMMEN MEDICAL AG
- Product Code
- DZE
- UDI-DI
- 07640156471489
- PMA / PMN Number
- K072649
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
PRIMARY STABILITY AND OSSEOINTEGRATION ACHIEVED. THE PROSTHETIC PART GOT UNSCREWED DUE TO THE BREAKAGE OF THE IMPLANT COLLAR. THE INCLUDED X-RAYS DID NOT GIVE ANY FURTHER EXPLANATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 782109 | ELEMENT IMPLANT, PF 4,5, E 4,2, L 11,0 | DENTAL IMPLANT | DZE | THOMMEN MEDICAL AG | 4.13.911 | 7960 | 07640156471489 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |