FDA Adverse Event
Injury
Summary report: N
CORTEX SCREW S.T. Ø4.5X70MM
MDR report key: 3063333
·
Received April 17, 2013
Report
- Report Number
- 0008031020-2013-00101
- Event Type
- Injury
- Date Received
- April 17, 2013
- Date of Event
- February 20, 2013
- Report Date
- March 20, 2013
- Manufacturer
- STRYKER OSTEOSYNTHESIS-SELZACH
- Product Code
- HWC
- PMA / PMN Number
- K001614
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT IN WITH A FAILED SCREW AND SIDEPLATE. SURGEON REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 165380 | CORTEX SCREW S.T. Ø4.5X70MM | IMPLANT | HWC | STRYKER OSTEOSYNTHESIS-SELZACH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention |