CM TITAMAX EX ACQUA IMPLANT 4.0X15
Report
- Report Number
- 3008261720-2019-00277
- Event Type
- Injury
- Date Received
- January 15, 2019
- Date of Event
- November 28, 2018
- Report Date
- February 8, 2019
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878016588
- PMA / PMN Number
- K133592
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- DENTIST
Narratives
THE DEVICE WAS SENT TO THE MANUFACTURER IN A MANNER UNSUITABLE FOR INVESTIGATION. EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. THE DEVICE WAS NOT RECEIVED BY THE MANUFACTURER. 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. THE INVESTIGATION OF THE COMPLAINT WAS CARRIED OUT CONSIDERING THE ANALYSIS OF THE INFORMATION GIVEN BY THE DENTIST IN THE GUARANTEE FORM.
THE DEVICE WAS SENT TO THE MANUFACTURER IN A MANNER UNSUITABLE FOR INVESTIGATION. EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT, JJGC.
THE PLACEMENT/REMOVAL DATES OF THE IMPLANT WERE REQUESTED FROM THE INITIAL REPORTER. THE BEST ESTIMATE OF THE DATE OF EVENT WAS PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INFORMATION BECOMES AVAILABLE. THE DEVICE WAS SENT TO THE MANUFACTURER IN A MANNER UNSUITABLE FOR INVESTIGATION. EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.
THE CLINICIAN REPORTED THAT 15.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 22 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE I BONE. THE IMPLANT WAS TORQUED MANUALLY TO 50 NCM. THERE WERE NO REPORTED PATIENT COMPLICATIONS. (B)(4).
THE CLINICIAN REPORTED THAT 15.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 22 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE I BONE. THE IMPLANT WAS TORQUED MANUALLY TO 50 NCM. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
THE CLINICIAN REPORTED THAT AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 21 IN THE MOUTH, THE IMPLANT FAILED IN TYPE I BONE. THE IMPLANT WAS TORQUED MANUALLY TO 50 NCM. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 42296 | CM TITAMAX EX ACQUA IMPLANT 4.0X15 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 94899 | 07899878016588 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |