FDA Adverse Event
Injury
Summary report: N
TOUAREG S DENTAL IMPLANT
MDR report key: 18845508
·
Received March 6, 2024
Report
- Report Number
- 3007518363-2024-30994
- Event Type
- Injury
- Date Received
- March 6, 2024
- Date of Event
- October 27, 2022
- Report Date
- October 27, 2022
- Manufacturer
- ADIN DENTAL IMPLANT SYSTEMS LTD
- Product Code
- DZE
- PMA / PMN Number
- K081751
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DOCTOR REPORTED THAT THE DENTAL IMPLANT WAS REMOVED AT TIME OF IMPLANTATION DUE TO FRACTURE OF DRIVER'S TIP INSIDE THE IMPLANT. THIS FRACTURE MAY BLOCK IMPLANT CONNECTION AND COULD LEAD TO FAILURE TO ADJUST THE IMPLANT CORRECTLY IN PLACE AND ALSO COULD IMPAIR IMPLANT RESTORATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO IRREGULARITIES FOUND IN INSPECTED ITEMS EVALUATED BY MANUFACTURER. FAILURE NOT RELATED TO IMPLANT'S QUALITY.
Description of Event or Problem · 0
DENTAL IMPLANT REMOVAL AT TIME OF IMPLANTATION DUE TO FRACTURE OF DENTAL HAND INSTRUMENT INSIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1669245 | TOUAREG S DENTAL IMPLANT | DENTAL IMPLANT | DZE | ADIN DENTAL IMPLANT SYSTEMS LTD | ISPS1335 | 7564909 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |