FDA Adverse Event
Injury
Summary report: N
INCORE LAPIDUS SYSTEM
MDR report key: 9727601
·
Received February 19, 2020
Report
- Report Number
- 3009540749-2020-00007
- Event Type
- Injury
- Date Received
- February 19, 2020
- Date of Event
- December 23, 2019
- Report Date
- February 19, 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 (B)(6) 2019. POST OPERATION, THE MEDIAL AND LATERAL SCREWS BROKE NEAR THE JUNCTION WITH THE POST. IT WAS REPORTED THAT THE DEVICE REMAINS IMPLANTED BUT A REVISION SURGERY MAY BE NECESSARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 193830 | INCORE LAPIDUS SYSTEM | BONE SCREW | HWC | NEXTREMITY SOLUTIONS | R17684, R17651 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |