FDA Adverse Event
Injury
Summary report: N
SILASTIC H.P. SWANSON FINGER JOINT (SWANSON DESIGN)
MDR report key: 69810
·
Received February 14, 1997
Report
- Report Number
- 1816403-1997-00055
- Event Type
- Injury
- Date Received
- February 14, 1997
- Report Date
- January 14, 1997
- Manufacturer
- DOW CORNING CORP.
- Product Code
- KWF
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
H6 - RESULTS: SHEAR SEPARATION; CONCLUSIONS: - SEPARATION IS CONDITION OF EXPOSURE WHILE IMPLANTED. RESULTS: 10 - WEAR MARKS. 100 - AMBER COLOR. CONCLUSIONS: - AMBER COLOR CONDITION OF AGING. - NO MFG RELATED DEFECTS FOUND.
Description of Event or Problem · 1
PHYSICIAN'S NOTES STATES "THESE IMPLANTS WERE IN FOR 20 YEARS IN A YOUNG VERY ACTIVE PATIENT. I THINK IT'S GREAT THEY LASTED EVEN THIS LONG. NO REACTION TO THE FRACTURED IMPLANTS OF SIGNIFICANCE WAS NOTED".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILASTIC H.P. SWANSON FINGER JOINT (SWANSON DESIGN) Implant | FINGER JOINT IMPLANT | KWF | DOW CORNING CORP. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Other| R |