FDA Adverse Event
Malfunction
Summary report: N
IMPLANT, ENDOSSEOUS, ROOT-FORM
MDR report key: 17516360
·
Received August 11, 2023
Report
- Report Number
- MW5123309
- Event Type
- Malfunction
- Date Received
- August 11, 2023
- Report Date
- December 23, 2015
- Manufacturer
- IMPLANT DIRECT, LLC 27030 MALIBU HILLS RD., AGOURA
- 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 OSSEOFAILURES ARTICLE #S AND LOT #S UNKNOWN. THESE ARE NOT NOBEL BIOCARE IMPLANTS, BUT PER 21 CFR 803.22, IT IS REQUIRED THAT THE LOSSES BE REPORTED TO THE FDA. IT IS BELIEVED THAT THE IMPLANTS ARE MANUFACTURED BY IMPLANT DIRECT, LLC. PATIENT ID: (B)(6). 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 |
|---|---|---|---|---|---|---|---|
| 2192586 | IMPLANT, ENDOSSEOUS, ROOT-FORM | IMPLANT, ENDOSSEOUS, ROOT-FORM | DZE | IMPLANT DIRECT, LLC 27030 MALIBU HILLS RD., AGOURA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |