Sigma 269-100-070Recalls & reported problems
Alphatec Spine, Inc. · 70mm C-C BLADE, SIGMA · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190376270722), received between Dec 29, 2020 and Feb 19, 2021 — classified as 2 injuries.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2021Break
AFTER REMOVING THE DEVICE FROM PATIENT, THE SURGEON NOTICED METAL DEBRIS AND DAMAGE TO THE INSTRUMENT.
Patient problems: Insufficient Information
MAUDE report 11348161 ↗InjuryDec 29, 2020Break
ONE OF THE CLAWS THAT ATTACHES THE BLADE TO THE SCREW BROKE OFF WHEN ATTEMPTING TO CONNECT THE BLADE TO THE SIGMA RETRACTOR. THE EVENT CAUSED OVER A 30 MINUTE DAY IN THE CASE.
Patient problems: Insufficient Information
MAUDE report 11087360 ↗
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- Fathom MR2-102050Seaspine Orthopedics Corporation · RETRACTOR1 recall1 report
- Omni-Tract® 10269Integra Lifesciences Corporation · RETRACTOR1 recall0 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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