FDA Adverse Event
Injury
Summary report: N
120 DEG TI LOCKING SLEEVE
MDR report key: 1023282
·
Received April 1, 2008
Report
- Report Number
- 1719045-2008-00032
- Event Type
- Injury
- Date Received
- April 1, 2008
- Report Date
- March 12, 2008
- Manufacturer
- SYNTHES (USA)
- Product Code
- HSB
- PMA / PMN Number
- K932593
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION DRAWN, AS NO DEVICE WAS RETURNED.
Description of Event or Problem · 1
PATIENT WAS IMPLANTED WITH AN END CAP, LOCKING SLEEVE, SPIRAL BLADE, FEMORAL NAIL, AND LOCKING SCREW. PATIENT WAS REVISED AND ALL HARDWARE REMOVED AFTER POST X-RAY SHOWED SPIRAL BLADE BACK OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 120 DEG TI LOCKING SLEEVE | LOCKING SLEEVES | HSB | SYNTHES (USA) | NA | 4210959 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | LOCKING SCREW| FEMORAL NAIL| SPIRAL BLADE| END CAP |