FDA Adverse Event
Other
Summary report: N
STAYFUSE FUSION SYSTEM
MDR report key: 778862
·
Received November 6, 2006
Report
- Report Number
- 2030833-2006-00010
- Event Type
- Other
- Date Received
- November 6, 2006
- Date of Event
- August 29, 2006
- Report Date
- November 6, 2006
- Manufacturer
- NEXA ORTHOPEDICS, INC.
- Product Code
- LZJ
- PMA / PMN Number
- k022726
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT COMPLAINED OF CLAWING IN 1ST & 2ND DIGITS OF FOOT. SURGEON ELECTED TO REMOVE IMPLANTS FROM 1ST AND 2ND DIGITS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAYFUSE FUSION SYSTEM | INTERPHALANGEAL FUSION DEVICE | LZJ | NEXA ORTHOPEDICS, INC. | STA-D7 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other |