FDA Adverse Event
Other
Summary report: N
SMARTPIN
MDR report key: 371313
·
Received January 7, 2002
Report
- Report Number
- 9613278-2001-00018
- Event Type
- Other
- Date Received
- January 7, 2002
- Report Date
- April 6, 2001
- Manufacturer
- BIONX IMPLANTS LTD.
- Product Code
- MAI
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
PORTIONS OF 2.0MM PIN WERE PROTRUDING ABOVE THE SURFACE OF THE PATELLA. THE PROTRUDING SEGMENTS OF THE PIN WERE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMARTPIN | BIOABSORBABLE BONE FIXATION PIN | MAI | BIONX IMPLANTS LTD. | 2220XX (LENGTH UNK) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |