FDA Adverse Event
Malfunction
Summary report: N
TI TITAMAX EX IMPLANT (4.1) 4.0X9
MDR report key: 5014263
·
Received August 5, 2015
Report
- Report Number
- 3010593814-2015-01471
- Event Type
- Malfunction
- Date Received
- August 5, 2015
- Date of Event
- January 15, 2015
- Report Date
- May 4, 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 ONE MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #4 IT WAS VERIFIED ITS NON OSSEOINTEGRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 519096 | TI TITAMAX EX IMPLANT (4.1) 4.0X9 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT | N.A. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention |