Invictus 17092-01-01Recalls & reported problems
Alphatec Spine, Inc. · Head, Tabletop Rod Cutter · Class 1
All models of Invictus (96)
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 00190376367194), received between Oct 19, 2022 and Oct 19, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- Headache1
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 19, 2022Fracture; Fracture
DURING A CASE, THE SURGEON AND PA WERE CUTTING A 5.5MM COCR ROD WITH A TABLETOP ROD CUTTER. WHILE CUTTING THE ROD, A LARGE PIECE OF THE HEAD OF THE ROD CUTTER SHEARED OFF AND STRUCK THE PA IN THE FACE ABOVE THE EYE. THE SHEARED OFF PIECE OF METAL FLEW OFF, BROKE THROUGH HER PROTECTIVE EYE WEAR AND CAUSED A GASH, BLEEDING AND SWELLING ABOVE THE EYE. SHE HAD TO STOP WHAT SHE WAS DOING, COLLECT HERSELF, BREAK SCRUB AND STOP THE BLEEDING. IT WAS REPORTED SHE ALSO HAD A MINOR HEADACHE.
Patient problems: Headache; Laceration(s)
MAUDE report 15636418 ↗
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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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