FDA Adverse Event
Injury
Summary report: N
INTRAOSSEOUS FIXATION SYSTEM
MDR report key: 3187202
·
Received June 20, 2013
Report
- Report Number
- 3005039508-2013-00010
- Event Type
- Injury
- Date Received
- June 20, 2013
- Date of Event
- May 1, 2012
- Report Date
- May 21, 2013
- Manufacturer
- ORTHOHELIX SURGICAL DESIGNS, INC.
- Product Code
- HTY
- PMA / PMN Number
- K120165
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME, THE INVESTIGATION IS NOT COMPLETE. THE REPORT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
ON OR ABOUT (B)(6) 2012, THE PT UNDERWENT FOOT SURGERY, USING AN IFS IMPLANT FOR HAMMERTOE. IT IS REPORTED THE CORTICAL WALL BLEW OUT DORSALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281421 | INTRAOSSEOUS FIXATION SYSTEM | PIN, FIXATION, SMOOTH | HTY | ORTHOHELIX SURGICAL DESIGNS, INC. | IFS-075-22 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |