FDA Adverse Event
Malfunction
Summary report: N
BIOMET/IMPLANT INNOVATIONS INC. IMPLANT
MDR report key: 17516569
·
Received August 11, 2023
Report
- Report Number
- MW5123518
- Event Type
- Malfunction
- Date Received
- August 11, 2023
- Report Date
- November 4, 2011
- Manufacturer
- BIOMET/IMPLANT INNOVATIONS INC. 4555 RIVERSIDE DRI
- 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: PART AND LOT# ARE UNKNOWN. 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. IT IS BELIEVED THAT THE IMPLANT IS 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 |
|---|---|---|---|---|---|---|---|
| 564695 | BIOMET/IMPLANT INNOVATIONS INC. IMPLANT | IMPLANT, ENDOSSEOUS, ROOT-FORM | DZE | BIOMET/IMPLANT INNOVATIONS INC. 4555 RIVERSIDE DRI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |