FDA Adverse Event
Injury
Summary report: N
IMPLANT, ENDOSSEOUS, ROOT-FORM
MDR report key: 17516168
·
Received August 11, 2023
Report
- Report Number
- MW5123117
- Event Type
- Injury
- Date Received
- August 11, 2023
- Report Date
- December 19, 2012
- 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 ONE IMPLANT OSSEOFAILURE: THE IMPLANT RETURNED FOR THIS REPORT IS NOT A NOBEL BIOCARE IMPLANT AND, PER 21 CFR 803.22, IT IS REQUIRED THAT THE LOSS BE REPORTED TO THE FDA. NOBEL BIOCARE WAS UNABLE TO DETERMINE THE MANUFACTURER OF THIS IMPLANT. (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 |
|---|---|---|---|---|---|---|---|
| 563421 | IMPLANT, ENDOSSEOUS, ROOT-FORM | IMPLANT, ENDOSSEOUS, ROOT-FORM | DZE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |