FDA Adverse Event
Injury
Summary report: N
CORTEX SCREW
MDR report key: 2973578
·
Received February 22, 2013
Report
- Report Number
- 2520274-2013-01115
- Event Type
- Injury
- Date Received
- February 22, 2013
- Report Date
- January 25, 2013
- Manufacturer
- SYNTHES (USA)
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PART OR LOT NUMBER WAS PROVIDED AND NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED REGARDING A 95 DEGREE CONDYLAR PLATE WITH SCREWS IMPLANTED ON (B)(6) 2012 TO TREAT A SUBTROCHANTERIC FEMUR FRACTURE. IT WAS REPORTED THAT A PATIENT RADIOGRAPH, ON AN UNKNOWN DATE, IDENTIFIED VARUS AND NONUNION. THE SURGEON EXPLANTED THE CONDYLAR PLATE AND SCREWS AND RE-IMPLANTED A LOCKING PROXIMAL FEMORAL PLATE AND SCREWS ON (B)(6) 2013. THE SURGEON NOTED THAT NO HARDWARE WAS FOUND TO BE BROKEN. THIS IS REPORT NUMBER 2 OF 2 FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78098 | CORTEX SCREW | CORTEX SCREW | HWC | SYNTHES (USA) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |