FDA Adverse Event
Injury
Summary report: N
FIREBIRD SFS
MDR report key: 25191866
·
Received May 15, 2026
Report
- Report Number
- 2183449-2026-00029
- Event Type
- Injury
- Date Received
- May 15, 2026
- Date of Event
- March 15, 2026
- Report Date
- May 15, 2026
- Manufacturer
- BRADSHAW MEDICAL
- Product Code
- LXH
- UDI-DI
- 18257200047437
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TC
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE DID NOT RETURN FOR INVESTIGATION. IF THE DEVICE IS RETURNED AN INVESTIGATION WILL BE PERFORMED AND A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THE INSTRUMENT WAS DEFECTIVE. THERE WAS A DELAY IN THE CASE BY 30-MINUTES. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 274787 | FIREBIRD SFS | TORQUE LIMITING HANDLE | LXH | BRADSHAW MEDICAL | 52-1512 | 35269NL20 | 18257200047437 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |