FDA Adverse Event
Malfunction
Summary report: N
ENDOSSEOUS DENTAL IMPLANT
MDR report key: 17516349
·
Received August 11, 2023
Report
- Report Number
- MW5123298
- Event Type
- Malfunction
- Date Received
- August 11, 2023
- Report Date
- December 4, 2017
- Manufacturer
- UNKNOWN
- Product Code
- DZE
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
NOBEL BIOCARE USA HAS RECEIVED A REPORT OF IMPLANT OSSEOFAILURES: PART# AND LOT# UNKNOWN. THE IMPLANTS RETURNED FOR THIS REPORT ARE NOT NOBEL BIOCARE IMPLANTS AND, PER ?21 CFR 803.22, IT IS REQUIRED THAT THE LOSSES BE REPORTED TO THE FDA. NOBEL BIOCARE WAS UNABLE TO DETERMINE THE MANUFACTURER OF THESE IMPLANTS. (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 |
|---|---|---|---|---|---|---|---|
| 2219054 | ENDOSSEOUS DENTAL IMPLANT | IMPLANT, ENDOSSEOUS, ROOT-FORM | DZE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |