CM ALVIM ACQUA IMPL TI 5.0X13
Report
- Report Number
- 3008261720-2017-05286
- Event Type
- Injury
- Date Received
- November 14, 2017
- Date of Event
- March 22, 2017
- Report Date
- January 17, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878016670
- PMA / PMN Number
- K101207
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- DENTIST
Narratives
EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.
EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.
EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.
(B)(4) - THE CLINICIAN REPORTED THAT 11 DAYS AFTER THE DENTAL IMPLANT WAS PLACED IN THE PATIENT'S MOUTH NON-OSSEOINTEGRATION WAS OBSERVED. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
(B)(4)- THE CLINICIAN REPORTED THAT 11 DAYS AFTER THE DENTAL IMPLANT WAS PLACED IN THE PATIENT'S MOUTH NON-OSSEOINTEGRATION WAS OBSERVED. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
THE CLINICIAN REPORTED THAT 11 DAYS AFTER THE DENTAL IMPLANT WAS PLACED IN THE PATIENT'S MOUTH NON-OSSEOINTEGRATION WAS OBSERVED. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 810541 | CM ALVIM ACQUA IMPL TI 5.0X13 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 60745 | 07899878016670 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention |