FDA Adverse Event
Malfunction
Summary report: N
CM DRIVE IMPLANT 3.5X8
MDR report key: 5013610
·
Received August 5, 2015
Report
- Report Number
- 3010593814-2015-01624
- Event Type
- Malfunction
- Date Received
- August 5, 2015
- Date of Event
- May 19, 2015
- Report Date
- May 25, 2015
- Manufacturer
- NEODENT
- Product Code
- DZE
- PMA / PMN Number
- K123022
- 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 REPORTED THAT 3 YEARS AND 8 MONTHS AFTER THE IMPLANT WAS INSTALLED IN THE PATIENT'S MOUTH OCCURRED ITS FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 519168 | CM DRIVE IMPLANT 3.5X8 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT | NA | 800028306 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |