FDA Adverse Event
Injury
Summary report: N
CM DRIVE ACQUA IMPL TI 4.3X13
MDR report key: 7348887
·
Received March 19, 2018
Report
- Report Number
- 3008261720-2018-01292
- Event Type
- Injury
- Date Received
- March 19, 2018
- Date of Event
- February 15, 2018
- Report Date
- March 19, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878016533
- PMA / PMN Number
- K133592
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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 NEARLY 5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 23, THE IMPLANT HAD NOT YET ACHIEVED OSSEO- 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 NEARLY 5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 23, THE IMPLANT HAD NOT YET ACHIEVED OSSEO- 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 |
|---|---|---|---|---|---|---|---|
| 193544 | CM DRIVE ACQUA IMPL TI 4.3X13 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 800237143I | 07899878016533 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |