FDA Adverse Event
Injury
Summary report: N
FX SOLUTIONS
MDR report key: 12405574
·
Received September 1, 2021
Report
- Report Number
- 3009532798-2021-00130
- Event Type
- Injury
- Date Received
- September 1, 2021
- Date of Event
- July 28, 2021
- Report Date
- August 13, 2021
- Manufacturer
- FX SOLUTIONS
- Product Code
- PHX
- UDI-DI
- 03701037300312
- PMA / PMN Number
- K150488
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
THE EVENT TOOK PLACE OUTSIDE OF THE UNITED STATES (IN (B)(6)) AND WAS ASSOCIATED WITH A PRODUCT THAT IS ALSO CLEARED FOR THE MARKET WITHIN THE UNITED STATES.
Description of Event or Problem · 1
THE EVENT TOOK PLACE OUTSIDE OF THE UNITED STATES (IN (B)(6)) AND WAS ASSOCIATED WITH A PRODUCT THAT IS ALSO CLEARED FOR THE MARKET WITHIN THE UNITED STATES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1307511 | FX SOLUTIONS | REVERSED SHOULDER PROSTHESIS | PHX | FX SOLUTIONS | DIAMETER 40 mm ECCENTRIC | N2180 | 03701037300312 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |