FDA Adverse Event
Injury
Summary report: N
BL, Ø 4.8MM RC, SLA® 10MM, TIZR, NTP
MDR report key: 8984862
·
Received September 10, 2019
Report
- Report Number
- 0001222315-2019-01612
- Event Type
- Injury
- Date Received
- September 10, 2019
- Date of Event
- April 9, 2019
- Report Date
- September 9, 2019
- Manufacturer
- INSTITUT STRAUMANN AG
- Product Code
- DZE
- UDI-DI
- 07630031707369
- PMA / PMN Number
- K150938
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
"FIED." PATIENT PRESENTED WITH BONE TYPE III AND 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 |
|---|---|---|---|---|---|---|---|
| 777834 | BL, Ø 4.8MM RC, SLA® 10MM, TIZR, NTP | ENDOSSEOUS DENTAL IMPLANT | DZE | INSTITUT STRAUMANN AG | TH169 | 07630031707369 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |