FIREBIRD SFS 51-1480Recalls & reported problems
Orthofix US LLC · ROD GRIPPER · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 18257200045600), received between Apr 11, 2017 and Dec 17, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Component Missing1
- Detachment Of Device Component1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 17, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING A SCOLIOSIS SURGERY, THE SCREW OF THE GRIPPER MOVED OUT OF PLACE. SURGERY WAS COMPLETED WITH ANOTHER ROD GRIPPER THAT WAS INSIDE OF THE TRAY WITH NO ADVERSE EFFECTS TO THE PATIENT. REPORTING FOR A ONE HOUR TIME DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20955466 ↗MalfunctionMay 4, 2017Break; Detachment Of Device Component
INFORMATION PROVIDED STATES THAT THE SCREW BROKE OFF OF THE ROD GRIPPER DURING THE CASE. NO ADVERSE EFFECTS TO THE PATIENT. NO DELAY IN THE DURATION OF THE CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6545853 ↗MalfunctionApr 11, 2017Component Missing
INITIAL INFORMATION PROVIDED STATES THAT IT WAS NOTICED DURING INVENTORY INSPECTION THAT THE SCREW WAS MISSING FROM THE ROD GRIPPER. ADDITIONAL INFORMATION WAS PROVIDED STATING THAT THE ROD GRIPPER WAS USED DURING A CASE AND THE MISSING SCREW WAS NOTICED AFTER THE CASE. THE SCREW WAS NOT RETURNED WITH THE DEVICE FOR EVALUATION. THE LOCATION OF THE MISSING SCREW IS UNKNOWN.
Patient problems: No Code Available
MAUDE report 6480572 ↗
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 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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