FDA Adverse Event
Injury
Summary report: N
TI TITAMAX IMPLANT (4.1)3.75X9
MDR report key: 7380766
·
Received March 29, 2018
Report
- Report Number
- 3008261720-2018-01464
- Event Type
- Injury
- Date Received
- March 29, 2018
- Date of Event
- January 1, 2018
- Report Date
- March 29, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07898237566894
- PMA / PMN Number
- K101207
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. IN TELEPHONE CONTACT, THE DENTIST INFORMED THAT HE DID NOT HAVE INFORMATION ABOUT LOT NUMBER OF THE PRODUCT.
Description of Event or Problem · 1
RP 010946 ¿ THE DENTIST REPORTED THAT AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 223735 | TI TITAMAX IMPLANT (4.1)3.75X9 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 07898237566894 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |