FDA Adverse Event
Injury
Summary report: N
120 DEG TI LOCKING SLEEVE
MDR report key: 2893764
·
Received January 2, 2013
Report
- Report Number
- 1719045-2013-00002
- Event Type
- Injury
- Date Received
- January 2, 2013
- Report Date
- December 4, 2012
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HSB
- PMA / PMN Number
- K932593
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.
Description of Event or Problem · 1
PATIENT WAS IMPLANTED WITH TI CANNULATED FEMORAL NAIL CONSTRUCT ON (B)(6)2012. SINCE (B)(6) 2012, THE PATIENT HAD BEEN HAVING SLOW PROGRESS AS REVEALED THROUGH X-RAYS TAKEN ON AN UNKNOWN DATE. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2012 FOR REMOVAL OF HARDWARE IN THE LEFT FEMUR DUE TO A NON-UNION. PATIENT WAS REVISED WITH COMPETITORS HARDWARE. NO COMPLICATIONS FROM THE SURGERY WERE REPORTED. THIS IS 3 OF 6 REPORTS FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 878 | 120 DEG TI LOCKING SLEEVE | TI LOCKING SLEEVE | HSB | SYNTHES MONUMENT | 6514066 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Required Intervention | NAIL, HELICAL BLADE, SCREWS |