FDA Adverse Event
Malfunction
Summary report: N
TITAMAX IMPLANT WITH MOUHNT 3.3X11
MDR report key: 5013705
·
Received August 5, 2015
Report
- Report Number
- 3010593814-2015-01559
- Event Type
- Malfunction
- Date Received
- August 5, 2015
- Date of Event
- May 4, 2015
- Report Date
- May 19, 2015
- Manufacturer
- NEODENT
- Product Code
- DZE
- PMA / PMN Number
- K101207
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INSTRADENT USA, INC., IS SUBMITTING THE REPORT ON BEHALF OF (B)(4).
Description of Event or Problem · 1
(B)(4). THE DENTIST REPORTED THE FRACTURE OF A DENTAL IMPLANT 3 YEARS AFTER ITS INSTALLATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 517642 | TITAMAX IMPLANT WITH MOUHNT 3.3X11 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT | NA | 800020911 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |