FDA Adverse Event
Injury
Summary report: N
TI LCP DISTAL FEMUR PLATE
MDR report key: 2032607
·
Received March 23, 2011
Report
- Report Number
- 8030965-2011-00103
- Event Type
- Injury
- Date Received
- March 23, 2011
- Date of Event
- March 17, 2011
- Report Date
- March 17, 2011
- Manufacturer
- SYNTHES GMBH
- Product Code
- HRS
- PMA / PMN Number
- K062564
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
SYNTHES IS UNABLE TO PROVIDE THE DATE OF MANUFACTURE. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.
Description of Event or Problem · 1
A DEVICE REPORT FROM ITALY INDICATES PATIENT IMPLANTED WITH TI LCP DISTAL FEMUR PLATE ON (B)(6)-2011 HAD THE PLATE REMOVED ON (B)(6)-2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TI LCP DISTAL FEMUR PLATE | DISTAL FEMUR PLATE | HRS | SYNTHES GMBH | NA | 2451944 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | SCREW |