FDA Adverse Event
Injury
Summary report: N
SP, Ø 3.3MM RN, SLACT. 10MM, TIZR, GEF.
MDR report key: 9073571
·
Received September 16, 2019
Report
- Report Number
- 0009613348-2019-01865
- Event Type
- Injury
- Date Received
- September 16, 2019
- Date of Event
- April 17, 2019
- Report Date
- September 16, 2019
- Manufacturer
- INSTITUT STRAUMANN AG
- Product Code
- DZE
- UDI-DI
- 07630031715654
- PMA / PMN Number
- K090260
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 13 OF THE PATIENT'S MOUTH. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 867162 | SP, Ø 3.3MM RN, SLACT. 10MM, TIZR, GEF. | ENDOSSEOUS DENTAL IMPLANT | DZE | INSTITUT STRAUMANN AG | RE919 | 07630031715654 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |