FDA Adverse Event
Injury
Summary report: N
IMPLANT, ENDOSSEOUS, ROOT-FORM
MDR report key: 17516319
·
Received August 11, 2023
Report
- Report Number
- MW5123268
- Event Type
- Injury
- Date Received
- August 11, 2023
- Report Date
- February 12, 2015
- Manufacturer
- BIOMET/IMPLANT INNOVATIONS INC
- 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 TWO IMPLANT OSSEOFAILURES: PART AND LOT# ARE UNKNOWN. THE IMPLANTS RETURNED FOR THIS REPORT ARE NOT NOBEL BIOCARE IMPLANTS AND, PER 21 CFR 803.22, IT IS REQUIRED THAT THE LOSS BE REPORTED TO THE FDA. IT IS BELIEVED THAT THE IMPLANTS ARE MANUFACTURED BY BIOMET/IMPLANT INNOVATIONS INC. (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 |
|---|---|---|---|---|---|---|---|
| 2217792 | IMPLANT, ENDOSSEOUS, ROOT-FORM | IMPLANT, ENDOSSEOUS, ROOT-FORM | DZE | BIOMET/IMPLANT INNOVATIONS INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |