FIREBIRD SFS;FIREBIRD NXG 36-1512Recalls & reported problems
Orthofix US LLC · TORQUE LIMITING HANDLE · 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 18257200108824), received between Jun 13, 2017 and Jun 13, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Falling” (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 Falling1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2017Component Falling
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.
Patient problems: No Code Available
MAUDE report 6639167 ↗
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
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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