FDA Adverse Event
Injury
Summary report: N
CM DRIVE IMPLANT 5.0X11.5 MM
MDR report key: 7829899
·
Received August 29, 2018
Report
- Report Number
- 3008261720-2018-04137
- Event Type
- Injury
- Date Received
- August 29, 2018
- Date of Event
- April 3, 2018
- Report Date
- August 29, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07898237569291
- PMA / PMN Number
- K123022
- 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 REPORTON BEHALF OF NEODENT - JJGC.
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
(B)(4). THE DENTIST REPORTED THAT 1 MONTH AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, IMMEDIATE IMPLANT PROCEDURE WAS PERFORMED.
Description of Event or Problem · 0
(B)(4). THE DENTIST REPORTED THAT 1 MONTH AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, IMMEDIATE IMPLANT PROCEDURE WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 669605 | CM DRIVE IMPLANT 5.0X11.5 MM | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 800168088G | 07898237569291 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |