FDA Adverse Event
Malfunction
Summary report: N
FIREBIRD NXG
MDR report key: 6639167
·
Received June 13, 2017
Report
- Report Number
- 2183449-2017-00018
- Event Type
- Malfunction
- Date Received
- June 13, 2017
- Date of Event
- May 17, 2017
- Report Date
- June 12, 2017
- Manufacturer
- ORTHOFIX INC.
- Product Code
- LXH
- UDI-DI
- 18257200108824
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TWO DEVICES RETURNED FOR EVALUATION. IT IS UNKNOWN AS TO WHICH DEVICE WAS USED TO FINAL TIGHTEN SET SCREWS. 36-1512 TORQUE LIMITING HANDLE (1) LOT 200556-SH10 MANUFACTURE DATE 08/10/2016. 36-1512 TORQUE LIMITING HANDLE (1) LOT 101874-SB19 MANUFACTURE DATE 02/19/2016.
Description of Event or Problem · 1
INFORMATION PROVIDED STATES THAT PATIENT EXPERIENCED A FALL POST OP AND THE FORZA PTC CAGE MIGRATED, POSSIBLY DUE TO IMPROPER TORQUE DURING PLACEMENT OF SET SCREWS. SURGERY WAS PERFORMED ON (B)(6) 2017 TO REPLACE HARDWARE ON ONE SIDE OF CONSTRUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 418894 | FIREBIRD NXG | TORQUE LIMITING HANDLE | LXH | ORTHOFIX INC. | 36-1512 (2) | 18257200108824 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |