CM TITAMAX EX IMPLANT 4.0X13
Report
- Report Number
- 3008261720-2018-05740
- Event Type
- Injury
- Date Received
- December 5, 2018
- Date of Event
- November 10, 2018
- Report Date
- January 22, 2019
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07898237568867
- PMA / PMN Number
- K101945
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- DENTIST
Narratives
EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.
EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS SELECTED AN IMPLANT DESIGN WHICH IS NOT RECOMMENDED FOR THE PATIENT'S BONE QUALITY.
EXEMPTION NUMBER: E2015015. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS SELECTED AN IMPLANT DESIGN WHICH IS NOT RECOMMENDED FOR THE PATIENT'S BONE QUALITY. FOLLOW-UP BEING SENT IN ORDER TO CORRECT THE NAME OF THE IMPLANT.
THE CLINICIAN REPORTED THAT 2 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 21 IN THE MOUTH, THE IMPLANT LOST INTEGRATION IN TYPE II BONE. CLINICIAN NOTED THE PATIENT'S IMPLANT MOBILITY, BLEEDING AND INFLAMMATION. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST- OPERATIVE COMPLICATIONS.
THE CLINICIAN REPORTED THAT 2 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 21 IN THE MOUTH, THE IMPLANT LOST INTEGRATION IN TYPE II BONE. CLINICIAN NOTED THE PATIENT'S IMPLANT MOBILITY, BLEEDING AND INFLAMMATION. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST- OPERATIVE COMPLICATIONS. (B)(4).
THE CLINICIAN REPORTED THAT 2 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 21 IN THE MOUTH, THE IMPLANT LOST INTEGRATION IN TYPE II BONE. CLINICIAN NOTED THE PATIENT'S IMPLANT MOBILITY, BLEEDING AND INFLAMMATION. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST- OPERATIVE COMPLICATIONS. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 974286 | CM TITAMAX EX IMPLANT 4.0X13 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 800324832 | 07898237568867 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention | NEOARCH MINICONICAL ABUTMENT PLACEMENT| NEOARCH MINICONICAL ABUTMENT PLACEMENT| NEOARCH MINICONICAL ABUTMENT PLACEMENT| NEOARCH MINICONICAL ABUTMENT PLACEMENT |