TI ALVIM IMPLANT (5.0) 5.0X10 MM
Report
- Report Number
- 3008261720-2019-01795
- Event Type
- Injury
- Date Received
- May 3, 2019
- Date of Event
- January 1, 2019
- Report Date
- May 3, 2019
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07898237567099
- PMA / PMN Number
- K101207
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- DENTIST
Narratives
EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. IN TELEPHONE CONTACT, IT WAS INFORMED THAT THE DENTIST DID NOT HAVE INFORMATION ABOUT LOT NUMBER OF THE PRODUCT. THE INVESTIGATION OF THE COMPLAINT WAS CARRIED OUT CONSIDERING THE ANALYSIS OF THE INFORMATION GIVEN BY THE DENTIST IN THE GUARANTEE FORM AND VISUAL CONFERENCE OF THE PRODUCT RETURNED BY THE DENTIST.
EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. IN TELEPHONE CONTACT, IT WAS INFORMED THAT THE DENTIST DID NOT HAVE INFORMATION ABOUT LOT NUMBER OF THE PRODUCT. THE INVESTIGATION OF THE COMPLAINT WAS CARRIED OUT CONSIDERING THE ANALYSIS OF THE INFORMATION GIVEN BY THE DENTIST IN THE GUARANTEE FORM AND VISUAL CONFERENCE OF THE PRODUCT RETURNED BY THE DENTIST.
(B)(4). THE DENTIST REPORTED THAT AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED.
(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 |
|---|---|---|---|---|---|---|---|
| 373280 | TI ALVIM IMPLANT (5.0) 5.0X10 MM | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 07898237567099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |