FDA Adverse Event
Injury
Summary report: N
BLT Ø4.1MM RC, SLACTIVE® 10MM, TIZR, NTP
MDR report key: 8977490
·
Received September 9, 2019
Report
- Report Number
- 0001222315-2019-01202
- Event Type
- Injury
- Date Received
- September 9, 2019
- Date of Event
- April 10, 2019
- Report Date
- September 9, 2019
- Manufacturer
- INSTITUT STRAUMANN AG
- Product Code
- DZE
- UDI-DI
- 07630031707031
- PMA / PMN Number
- K140878
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
FIED. PATIENT PRESENTED WITH INADEQUATE BONE QUALITY / QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THE PATIENT EXPERIENCED THE FOLLOWING AT THE TIME OF EVENT: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 770154 | BLT Ø4.1MM RC, SLACTIVE® 10MM, TIZR, NTP | ENDOSSEOUS DENTAL IMPLANT | DZE | INSTITUT STRAUMANN AG | TG391 | 07630031707031 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |