FDA Adverse Event
Injury
Summary report: N
BL, Ø 4.1MM RC, SLA® 12MM, TI, LOXIM
MDR report key: 8977580
·
Received September 9, 2019
Report
- Report Number
- 0001222315-2019-01268
- Event Type
- Injury
- Date Received
- September 9, 2019
- Date of Event
- April 4, 2019
- Report Date
- September 9, 2019
- Manufacturer
- INSTITUT STRAUMANN AG
- Product Code
- DZE
- UDI-DI
- 07630031707000
- PMA / PMN Number
- K062129
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
'FIED'. THE DEVICE WAS FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THE PATIENT EXPERIENCED THE FOLLOWING AT THE TIME OF EVENT: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 771998 | BL, Ø 4.1MM RC, SLA® 12MM, TI, LOXIM | ENDOSSEOUS DENTAL IMPLANT | DZE | INSTITUT STRAUMANN AG | PZ353 | 07630031707000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |