FDA Adverse Event
Injury
Summary report: N
CM ALVIM ACQUA IMPL TI 3.5X11.5
MDR report key: 7656098
·
Received July 2, 2018
Report
- Report Number
- 3008261720-2018-02936
- Event Type
- Injury
- Date Received
- July 2, 2018
- Date of Event
- June 2, 2018
- Report Date
- July 2, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878016717
- PMA / PMN Number
- K150199
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- 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
THE CLINICIAN REPORTED THAT 2 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN THE MOUTH, IT HAD NOT ACHIEVED INTEGRATION. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS. (B)(4).
Description of Event or Problem · 0
THE CLINICIAN REPORTED THAT 2 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN THE MOUTH, IT HAD NOT ACHIEVED INTEGRATION. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 497435 | CM ALVIM ACQUA IMPL TI 3.5X11.5 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 800304219 | 07899878016717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Required Intervention |