FDA Adverse Event
Injury
Summary report: N
IMPLANT, ENDOSSEOUS, ROOT-FORM
MDR report key: 17516246
·
Received August 11, 2023
Report
- Report Number
- MW5123195
- Event Type
- Injury
- Date Received
- August 11, 2023
- Report Date
- September 18, 2018
- Manufacturer
- IMPLANT DIRECT LLC
- 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 AN OSSEOFAILURE FOR ONE IMPLANT; ARTICLE # AND LOT # UNKNOWN. THIS IS NOT A NOBEL BIOCARE IMPLANT, BUT 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 IMPLANT DIRECT, LLC. (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 |
|---|---|---|---|---|---|---|---|
| 869879 | IMPLANT, ENDOSSEOUS, ROOT-FORM | IMPLANT, ENDOSSEOUS, ROOT-FORM | DZE | IMPLANT DIRECT LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |