FDA Adverse Event
Injury
Summary report: N
INCORE LAPIDUS SYSTEM
MDR report key: 9770839
·
Received February 28, 2020
Report
- Report Number
- 3009540749-2020-00009
- Event Type
- Injury
- Date Received
- February 28, 2020
- Report Date
- February 28, 2020
- Manufacturer
- NEXTREMITY SOLUTIONS
- Product Code
- HWC
- PMA / PMN Number
- K180257
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
IF ADDITIONAL INFORMATION IS OBTAINED WHICH CHANGES THE OUTCOME OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.
Description of Event or Problem · 1
A SURGERY WAS PERFORMED WITH THE INCORE LAPIDUS SYSTEM ON AN UNKNOWN DATE, AND IT WAS REPORTED THAT A NON-UNION OCCURED WHICH WAS CONFIRMED THROUGH AN X-RAY IMAGE. PER THE REPORTER REVISION DID NOT OCCUR AND WAS NOT PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 232363 | INCORE LAPIDUS SYSTEM | BONE SCREW | HWC | NEXTREMITY SOLUTIONS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |