FDA Adverse Event
Injury
Summary report: N
IMPLANT, ENDOSSEOUS, ROOT-FORM
MDR report key: 17516258
·
Received August 11, 2023
Report
- Report Number
- MW5123207
- Event Type
- Injury
- Date Received
- August 11, 2023
- Report Date
- April 6, 2015
- Manufacturer
- BIOMET/IMPLANT INNOVATIONS INC BIOME/LMPLANT INNOV
- 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 IMPLANTS 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 |
|---|---|---|---|---|---|---|---|
| 595463 | IMPLANT, ENDOSSEOUS, ROOT-FORM | IMPLANT, ENDOSSEOUS, ROOT-FORM | DZE | BIOMET/IMPLANT INNOVATIONS INC BIOME/LMPLANT INNOV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |