FDA Adverse Event
Malfunction
Summary report: N
CM ALVIM IMPLANT 3.5X8
MDR report key: 5014789
·
Received August 5, 2015
Report
- Report Number
- 3010593814-2015-01880
- Event Type
- Malfunction
- Date Received
- August 5, 2015
- Date of Event
- April 27, 2015
- Report Date
- June 26, 2015
- Manufacturer
- NEODENT - AVENIDA JUSCELINO KUBITSCHEK DE OLIVEIRA, 3291 CIC
- Product Code
- DZE
- PMA / PMN Number
- K101945
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INSTRADENT USA, INC. IS SUBMITTING THE REPORT ON BEHALF OF (B)(4).
Description of Event or Problem · 1
(B)(4). THE DENTIST DECIDED TO REMOVE A DENTAL IMPLANT INSTALLED IN INTRAORAL REGION #12 BECAUSE PATIENT PRESENTED PERI-IMPLANTITIS AND PROGRESSIVE BONE LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 515730 | CM ALVIM IMPLANT 3.5X8 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - AVENIDA JUSCELINO KUBITSCHEK DE OLIVEIRA, 3291 CIC | NA | 800070025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |