FDA Adverse Event
Other
Summary report: N
STAY FUSE
MDR report key: 758956
·
Received September 6, 2006
Report
- Report Number
- 2030833-2006-00007
- Event Type
- Other
- Date Received
- September 6, 2006
- Date of Event
- July 14, 2006
- Report Date
- September 5, 2006
- Manufacturer
- NEXA ORTHOPEDICS
- Product Code
- KWH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
510 K INITIALLY GRANTED TO PIONEER SURGICAL TECHNOLOGY. NEXA PURCHASED PRODUCT LINE FROM PIONEER IN 2005.
Description of Event or Problem · 1
PT PRESENTED FOR FOLLOW-UP AFTER IMPLANTATION OF STAY FUSE DEVICE. RADIOGRAPHS AT FOLLOW-UP INDICATED SEPARATION OF STAY FUSE DEVICES. SURGEON, IN 2006, EXPLANTED ONE HALF OF STAY FUSE PAIR AND REPLACED EXPLANTED COMPONENT WITH A NEW DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAY FUSE | TOE FUSION DEVICE | KWH | NEXA ORTHOPEDICS | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Other |