FDA Adverse Event
Injury
Summary report: N
CM TITAMAX EX IMPLANT 3.75X13
MDR report key: 7011126
·
Received November 8, 2017
Report
- Report Number
- 3008261720-2017-00246
- Event Type
- Injury
- Date Received
- November 8, 2017
- Date of Event
- January 1, 2015
- Report Date
- August 13, 2015
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07898237569154
- PMA / PMN Number
- K101945
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- 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
OS 111515 - THE DENTIST REPORTED THAT 2 WEEKS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #9 IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. IMPLANT WAS IMMEDIATELY CARRIED OUT, 60 NCM OF PRIMARY STABILITY WAS ACHIEVED, AND IMMEDIATE LOAD WAS EXECUTED. PATIENT PRESENTED BONE TYPE III AND BONE GRAFT WAS EXECUTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 789157 | CM TITAMAX EX IMPLANT 3.75X13 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 07898237569154 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |