FDA Adverse Event
Injury
Summary report: N
CM TITAMAX EX IMPLANT 3.75X9
MDR report key: 7012658
·
Received November 9, 2017
Report
- Report Number
- 3008261720-2017-00306
- Event Type
- Injury
- Date Received
- November 9, 2017
- Date of Event
- July 27, 2015
- Report Date
- August 21, 2015
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07898237569130
- PMA / PMN Number
- K133592
- 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 111732 - THE DENTIST REPORTED THAT FOUR MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #19 IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. THIRTY-FIVE NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT EXECUTED. THE PATIENT PRESENTED BONE TYPE III.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 793549 | CM TITAMAX EX IMPLANT 3.75X9 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 800114010 | 07898237569130 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |