FDA Adverse Event
Malfunction
Summary report: N
TI TITAMAX EX IMPLANT(4.1) 3.75X13
MDR report key: 4965032
·
Received July 14, 2015
Report
- Report Number
- 3010593814-2015-01250
- Event Type
- Malfunction
- Date Received
- July 14, 2015
- Date of Event
- January 15, 2015
- Report Date
- March 26, 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 THAT 2 DAYS AFTER THE DENTAL IMPLANTS WAS INSTALLED IN THE PATIENT'S MOUTH, VERIFIED THE LOSS OF THE IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 458336 | TI TITAMAX EX IMPLANT(4.1) 3.75X13 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT | N.A. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | N.A. |