FDA Adverse Event
Injury
Summary report: N
4.5MM LCP CURVED CONDYLAR PLATE 12 HOLES/278MM-R
MDR report key: 2221248
·
Received August 17, 2011
Report
- Report Number
- 3003506883-2011-00513
- Event Type
- Injury
- Date Received
- August 17, 2011
- Report Date
- July 25, 2011
- Manufacturer
- SYNTHES ELMIRA
- Product Code
- KTT
- PMA / PMN Number
- K041911
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
PRODUCT SERVICE. THE DHR REVIEW FOUND ALL RELEASED PARTS FOR THE SUBJECT PRODUCT LOT MET VISUAL AND DIMENSIONAL CRITERIA AT THE TIME OF MFR AND RELEASE. NO PRODUCT SAMPLE WAS RETURNED FOR EVALUATION. 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 A CLINIC IN (B)(6) REPORTED: PT EXPERIENCED A FALL AND INCURRED A DISLOCATED DISTAL MULTI FRAGMENTAL FEMUR FRACTURE ON THE RIGHT SIDE WAS IMPLANTED ON (B)(6) 2011 WITH A 4.5 MM LCP CURVED CONDYLAR PLATE AND SCREWS. ON (B)(6) 2011, IT WAS NOTED ON X-RAY THE PLATE WAS BROKEN. IT IS NOT KNOWN IF THE PLATE WAS REMOVED AND/OR THE PT REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.5MM LCP CURVED CONDYLAR PLATE 12 HOLES/278MM-R | LCP CURVED CONDYLAR PLATE | KTT | SYNTHES ELMIRA | 5414801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | SCREW.| SCREW |