FDA Adverse Event
Injury
Summary report: N
4.5MM LCP® CURVED CONDYLAR PLATE 10 HOLES/242MM-RIGHT
MDR report key: 2921185
·
Received January 17, 2013
Report
- Report Number
- 3003506883-2013-00030
- Event Type
- Injury
- Date Received
- January 17, 2013
- Date of Event
- December 19, 2012
- Report Date
- December 19, 2012
- Manufacturer
- SYNTHES ELMIRA
- Product Code
- KTT
- PMA / PMN Number
- K041911
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV
- Reporter Occupation
- HEALTH PROFESSIONAL
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 SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.
Description of Event or Problem · 1
ON (B)(6) 2012, PATIENT WAS IMPLANTED WITH LCP CONDYLAR PLATE AND SCREW CONSTRUCT. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2012 FOR REMOVAL OF DISTAL FEMUR HARDWARE DUE TO NON-UNION OF RIGHT FEMUR FRACTURE. INFECTION WAS DOCUMENTED ON INCISION. THE SURGEON REMOVED ALL HARDWARE; THE PATIENT WAS REVISED WITH EXTERNAL FIXATOR AND WITH ANTIBIOTIC CEMENT SPACER. PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THIS IS 1 OF 15 REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26209 | 4.5MM LCP® CURVED CONDYLAR PLATE 10 HOLES/242MM-RIGHT | PLATE | KTT | SYNTHES ELMIRA | 6261720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention | SCREWS |