FDA Adverse Event
Malfunction
Summary report: N
SFS SECOND GENERATION CROSS CONNECTOR
MDR report key: 2432580
·
Received January 20, 2012
Report
- Report Number
- 3008524126-2011-00044
- Event Type
- Malfunction
- Date Received
- January 20, 2012
- Date of Event
- October 31, 2011
- Report Date
- January 20, 2012
- Manufacturer
- ORTHOFIX INC.
- Product Code
- MNI
- PMA / PMN Number
- K003735
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
BASED ON INFO PROVIDED, THE CROSS CONNECTORS BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SFS SECOND GENERATION CROSS CONNECTOR | 35MM MULTI-AXIAL CROSS CONNECTOR | MNI | ORTHOFIX INC. | 55-5335 | B38 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |