FDA Adverse Event
Injury
Summary report: N
4.5MM CORTEX SCREWS
MDR report key: 1080804
·
Received July 17, 2008
Report
- Report Number
- 1719045-2008-00090
- Event Type
- Injury
- Date Received
- July 17, 2008
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HWC
- PMA / PMN Number
- K974537
- Adverse Event
- Yes
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.5MM CORTEX SCREWS | CORTEX SCREWS | HWC | SYNTHES MONUMENT | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |