FDA Adverse Event
Injury
Summary report: N
GM HELIX ACQUA IMPLANT 3.75X11.5
MDR report key: 7456145
·
Received April 24, 2018
Report
- Report Number
- 3008261720-2018-01914
- Event Type
- Injury
- Date Received
- April 24, 2018
- Date of Event
- March 19, 2018
- Report Date
- April 24, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878025238
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 0
EXEMPTION NUMBER: E2015015. CONSIDERING THE SURGICAL METHODOLOGY, THE DENTIST REPORTED THAT THE IMPLANT WAS IMMEDIATELY INSTALLED IN AN ALVEOLUS WITH SIGNS OF INJURY/ INFECTION. THE PREMARKET ID IS K163194.
Description of Event or Problem · 0
(B)(4) - THE DENTIST REPORTED THAT AFTER 1 MONTH DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 12#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 40 NCM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE III, IMMEDIATE IMPLANT AND IMMEDIATE LOAD WERE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299368 | GM HELIX ACQUA IMPLANT 3.75X11.5 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 800311927 | 07899878025238 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |