FDA Adverse Event
Injury
Summary report: N
3.5MM CORTEX SCREW SELF-TAPPING 14MM
MDR report key: 2659278
·
Received July 11, 2012
Report
- Report Number
- 1719045-2012-00714
- Event Type
- Injury
- Date Received
- July 11, 2012
- Report Date
- June 14, 2012
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HWC
- PMA / PMN Number
- K112583
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
PT STATUS POST PLATE AND SCREW IMPLANTATION ON 01/03/2012 RETURNED TO SURGEON COMPLAINING OF PAIN OR AN UNK DATE. PT WAS RETURNED TO OPERATING ROOM ON (B)(6) 2012, ALL HARDWARE WAS REMOVED, PT WAS NOT REVISED TO NEW HARDWARE. SURGEON NOTED THE FRACTURE WAS HEALED. THIS IS 3 OF 9 REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.5MM CORTEX SCREW SELF-TAPPING 14MM | CORTEX SCREW SELF-TAPPING | HWC | SYNTHES MONUMENT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention | PLATE| SCREW |