FDA Adverse Event
Injury
Summary report: N
CM DRIVE IMPLANT 4.3X10 MM
MDR report key: 7030011
·
Received November 14, 2017
Report
- Report Number
- 3008261720-2017-05195
- Event Type
- Injury
- Date Received
- November 14, 2017
- Date of Event
- May 3, 2017
- Report Date
- January 22, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878023333
- PMA / PMN Number
- K123022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 0
EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. AFTER THE EVALUATION WAS NOTICED THAT THE ITEM RECEIVED IS DIFFERENT FROM THE ITEM REPORTED ON GUARANTEE FORM BY THE COMPLAINANT. THEREFORE, THE LOT NUMBER WAS NOT CONSIDERED.
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
(B)(4) -THE CLINICIAN REPORTED THAT THE DENTAL IMPLANT FAILED.
Description of Event or Problem · 0
THE CLINICIAN REPORTED THAT THE DENTAL IMPLANT FAILED. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION.
Description of Event or Problem · 0
(B)(4). THE CLINICIAN REPORTED THAT THE DENTAL IMPLANT FAILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 807401 | CM DRIVE IMPLANT 4.3X10 MM | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 07899878023333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |