FDA Adverse Event
Injury
Summary report: N
CM ALVIM IMPLANT 4.3X10
MDR report key: 7168254
·
Received January 5, 2018
Report
- Report Number
- 3008261720-2018-00055
- Event Type
- Injury
- Date Received
- January 5, 2018
- Date of Event
- January 12, 2017
- Report Date
- January 5, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07898237568966
- 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
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 AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED.
Description of Event or Problem · 0
(B)(4). THE DENTIST REPORTED THAT AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 13731 | CM ALVIM IMPLANT 4.3X10 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 07898237568966 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |