FIREBIRD SFS 52-1080Recalls & reported problems
Orthofix US LLC · ROD GRIPPER · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18257200047048), received between Nov 16, 2015 and Nov 16, 2015 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Component Missing1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 16, 2015Component Missing
INFORMATION PROVIDED STATES THAT A SCREW FROM THE FIREBIRD ROD HOLDER WAS MISSING WHEN THE TRAY WAS RECEIVED BY STERILE SERVICES AFTER A FRACTURED SPINE PROCEDURE. IT WAS LATER FOUND THAT THE SCREW WAS IN THE PATIENT. THE PATIENT WAS INFORMED. IT WAS DECIDED BY THE SURGEON NOT TO OPERATE TO REMOVE THE SCREW.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 5225685 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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