FDA Adverse Event
Other
Summary report: N
FIXION INTERLOCKING PF NAILING SYSTEM
MDR report key: 412660
·
Received August 18, 2002
Report
- Report Number
- 9615128-2002-00003
- Event Type
- Other
- Date Received
- August 18, 2002
- Date of Event
- July 1, 2002
- Report Date
- July 19, 2002
- Manufacturer
- DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
- Product Code
- HSB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IN AN X-RAY TAKEN ABOUT 10 WEEKS AFTER THE SURGERY, THE DISTAL EXPANDABLE SECTION OF THE HIP PEG SEEMS TO BE DETACHED FROM THE RIGID, PROXIMAL SHAFT. AT THE AREA OF WELDING OF THE PARTS. ALTHOUGH NOT CONFIRMED IT MAY BE THAT THE PATIENT FELL (AS PER THEIR PHYSICIAN). ACCORDING TO THE REPORT OF JULY 2002 THE PATIENT IS WALKING AND SOME CALLUS IS SEEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FIXION INTERLOCKING PF NAILING SYSTEM | INTRAMEDULLARY NAIL | HSB | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. | NA | FP01179 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |