FDA Adverse Event
Injury
Summary report: N
OSSEOSPEED TX 3.5S - 13 MM
MDR report key: 11955547
·
Received June 8, 2021
Report
- Report Number
- 9612468-2021-38829
- Event Type
- Injury
- Date Received
- June 8, 2021
- Date of Event
- August 20, 2019
- Report Date
- May 17, 2021
- Manufacturer
- DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)
- Product Code
- DZE
- PMA / PMN Number
- K053384
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 855785 | OSSEOSPEED TX 3.5S - 13 MM | IMPLANT, ENDOSSEOUS, ROOT-FORM | DZE | DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |