FDA Adverse Event
Malfunction
Summary report: N
SCS SCREWDRIVER SHORT HANDLE
MDR report key: 117098
·
Received August 29, 1997
Report
- Report Number
- 1222315-1997-00295
- Event Type
- Malfunction
- Date Received
- August 29, 1997
- Date of Event
- July 24, 1997
- Report Date
- August 25, 1997
- Manufacturer
- INSTITUT STRAUMANN AG
- Product Code
- EJB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
THE CLINICIAN REPORTS THAT THE PT SWALLOWED A SCS SCREWDRIVER INSERT. THE PT WENT TO THE HOSPITAL FOR A CHEST X-RAY. THE X-RAY WAS NEGATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCS SCREWDRIVER SHORT HANDLE Implant | INSTRUMENT | EJB | INSTITUT STRAUMANN AG | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |