FDA Adverse Event
Injury
Summary report: N
3.5MM TI CORTEX SCREW 36MM
MDR report key: 2150517
·
Received June 23, 2011
Report
- Report Number
- 8030965-2011-00292
- Event Type
- Injury
- Date Received
- June 23, 2011
- Report Date
- May 31, 2011
- Manufacturer
- SYNTHES GMBH
- Product Code
- HWC
- PMA / PMN Number
- PREAMEND
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS ON GOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE MANUFACTURING RECORDS HAS BEEN REQUESTED.
Description of Event or Problem · 1
PATIENT INVOLVED IN MOTOR VEHICLE ACCIDENT AND SUSTAINED A DISTAL TIBIA AND FIBULA FRACTURE. TIBIA FRACTURE TREATED WITH LCP PLATE AND CORTEX SCREWS. FIBULA FRACTURE TREATED WITH THIRD TUBULAR PLATE AND CORTEX SCREWS. THREE SCREWS BROKE POSTOPERATIVELY. THIS IS THE 3RD OF 3 REPORTS SUBMITTED ON THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.5MM TI CORTEX SCREW 36MM | CORTEX SCREW | HWC | SYNTHES GMBH | NA | 3265528 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | SCREWS| PLATES |