FDA Adverse Event
Injury
Summary report: N
WS TITAMAX IMPLANT 4.0X5
MDR report key: 7297980
·
Received February 26, 2018
Report
- Report Number
- 3008261720-2018-00944
- Event Type
- Injury
- Date Received
- February 26, 2018
- Date of Event
- May 5, 2015
- Report Date
- February 26, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- 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. THE DEVICE DOES NOT HAVE A 510 (K), BUT WAS ONCE IMPROPERLY SOLD IN US AND IS BEING REPORTED SINCE THERE STILL ARE 2 UNITS INSTALLED IN PATIENTS.
Description of Event or Problem · 1
RP. 001419 - THE DENTIST REPORTED THAT 3 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THIRTY-FIVE NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD. THE PATIENT PRESENTED BONE TYPE III.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 139420 | WS TITAMAX IMPLANT 4.0X5 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 800078769 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |