FDA Adverse Event
Injury
Summary report: N
DENTAL IMPLANT
MDR report key: 17526808
·
Received August 12, 2023
Report
- Report Number
- MW5133745
- Event Type
- Injury
- Date Received
- August 12, 2023
- Date of Event
- October 6, 2021
- Report Date
- April 26, 2022
- Manufacturer
- UNKNOWN
- Product Code
- DZE
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
ENCLOSED PLEASE FIND ONE PAGE OF INFORMATION, ABOUT A MEDICAL DEVICE, THAT WAS REPORTED TO STRAUMANN USA AS DENTAL PROSTHESIS FAILURE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2243473 | DENTAL IMPLANT | IMPLANT, ENDOSSEOUS, ROOT-FORM | DZE | UNKNOWN | 12080921 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Unknown |