FDA Adverse Event
Injury
Summary report: N
TITAMAX SMART IMPLANT (4.1) 4.0X13
MDR report key: 7508967
·
Received May 11, 2018
Report
- Report Number
- 3008261720-2018-02213
- Event Type
- Injury
- Date Received
- May 11, 2018
- Date of Event
- October 26, 2017
- Report Date
- May 11, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07898237566771
- PMA / PMN Number
- K133510
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ES
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 0
EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.
Description of Event or Problem · 0
RP 011820 - THE DENTIST REPORTED THAT NEARLY 1 MONTH AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, IT HAD TO BE REMOVED BECAUSE THE PATIENT WAS IN PAIN. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349998 | TITAMAX SMART IMPLANT (4.1) 4.0X13 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 800118324 | 07898237566771 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |