FDA Adverse Event
Injury
Summary report: N
TI LCP DISTAL FEMUR PLATE
MDR report key: 2132560
·
Received June 10, 2011
Report
- Report Number
- 8030965-2011-00280
- Event Type
- Injury
- Date Received
- June 10, 2011
- Date of Event
- March 4, 2011
- Report Date
- May 25, 2011
- Manufacturer
- SYNTHES GMBH
- Product Code
- HRS
- PMA / PMN Number
- K062564
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION COULD NOT BE CONCLUDED AS NO DEVICE WAS RETURNED.
Description of Event or Problem · 1
PT EXPERIENCED A FEMORAL SHAFT FRACTURE ON (B)(6) 2010 AND WAS IMPLANTED WITH A LCP DISTAL FEMUR PLATE ON (B)(6) 2010. PT REHABILITATION BEGAN ON (B)(6) 2010 AND WAS DISCHARGED ON (B)(6)2011. ON (B)(6) 2011, PLATE WAS NOTED TO BE BROKEN AND FEMORAL BONE WAS RE-FRACTURED. THE PLATE WAS REMOVED AND REPLACED ON AN UNK DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TI LCP DISTAL FEMUR PLATE | LCP DISTAL FEMUR PLATE | HRS | SYNTHES GMBH | NA | 2584610 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |