FDA Adverse Event
Injury
Summary report: N
CM DRIVE IMPL TI 3.5X8
MDR report key: 7030006
·
Received November 14, 2017
Report
- Report Number
- 3008261720-2017-05188
- Event Type
- Injury
- Date Received
- November 14, 2017
- Date of Event
- May 16, 2017
- Report Date
- November 14, 2017
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07898237569307
- PMA / PMN Number
- K123022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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
ONLY IMPLANT WAS RETURNED FOR INVESTIGATION, BUT NO FURTHER INFORMATION. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Description of Event or Problem · 0
ONLY IMPLANT WAS RETURNED FOR INVESTIGATION, BUT NO FURTHER INFORMATION. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 807399 | CM DRIVE IMPL TI 3.5X8 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 800156350 | 07898237569307 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |