ASCENT LE 65-2200Recalls & reported problems
Orthofix US LLC · 200MM ROD, ASCENT LE/ASCENT POCT · Class 2
Data updated Oct 16, 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 18257200018581), received between May 10, 2016 and May 10, 2016 — classified as 1 malfunction.
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 16, 2026.
Most reported problems
Device problems
- Break1
- Detachment Of Device Component1
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.
MalfunctionMay 10, 2016Break; Detachment Of Device Component
INFORMATION PROVIDED STATES THAT 2 RODS BROKE INTO TREATMENT. PATIENT HAD OCCIPITAL TO C6 SURGERY SOME TIME AGO. ORIGINAL SURGERY INFORMATION IS NOT AVAILABLE. THE RODS BROKE AT THE TRANSITION POINT AT C2. THE RODS WERE REMOVED AND REPLACED WITH NEW RODS.
Patient problems: No Code Available
MAUDE report 5645685 ↗
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- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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