PHOENIX SFS 20-0214Recalls & reported problems
Orthofix US LLC · ROD HOLDER-INSERTER · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18257200028313), received between Aug 14, 2015 and Aug 17, 2015 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
Patient problems
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2015Break
INFORMATION PROVIDED STATES THAT DURING A LUMBAR FIXATION SURGERY ON (B)(6) 2015, THE TIP BROKE OFF THE ROD HOLDER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5008743 ↗MalfunctionAug 14, 2015Break
INFORMATION PROVIDED STATES THAT THE INSTRUMENT WAS BEING USED BY THE SALES REPRESENTATIVE DURING IN AN IN-SERVICE AT THE HOSPITAL WHEN THE TIP OF THE ROD INSERTER BROKE OFF. THIS WAS NOT DURING A CASE AND THERE WAS NO PATIENT/SURGEON CONTACT. THE MALFUNCTION COULD CAUSE THE DEVICE TO FAIL TO PERFORM ITS ESSENTIAL FUNCTION WHICH COULD LEAD TO DEATH, SERIOUS INJURY.
Patient problems: No Patient Involvement
MAUDE report 5003362 ↗
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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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