FDA Adverse Event
Injury
Summary report: N
DZE
MDR report key: 11943909
·
Received June 5, 2021
Report
- Report Number
- 9612468-2021-47301
- Event Type
- Injury
- Date Received
- June 5, 2021
- Date of Event
- March 26, 2021
- Report Date
- June 1, 2021
- Manufacturer
- DENTSPLY IMPLANTSS (A DIVISION OF DENTSPLY IH AB)
- Product Code
- DZE
- PMA / PMN Number
- K120414
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803.
Description of Event or Problem · 1
I WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 840437 | DZE | DZE | DENTSPLY IMPLANTSS (A DIVISION OF DENTSPLY IH AB) | NA | 458037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |