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Sigma 269-100-080Recalls & reported problems

Alphatec Spine, Inc. · 80mm C-C BLADE, SIGMA · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190376270739), received between Jan 12, 2021 and Oct 26, 2021 — classified as 1 injury, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1
  • Detachment of Device or Device Component1

Patient problems

  • Foreign Body In Patient1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 26, 2021Break; Break

    WHEN THE 80MM C/C BLADE WAS ATTACHED TO THE SCREW SHANK IN-SITU, THE WING BEETLE CLAMP THAT ATTACHES TO THE SCREW SHANK BROKE AWAY, COMPLETELY DETACHING FROM THE BLADE, AND THE BLADE FROM THE SCREW SHANK. THIS CAUSED A DELAY IN SURGERY. NO PATIENT INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12701176 ↗
  • InjuryJan 12, 2021Detachment of Device or Device Component

    THE RETRACTOR WAS REMOVED AND THE BLADE CAME OUT OF THE PATIENT MISSING THE WING. THE DETACHED WING WAS REMOVED FROM THE PATIENT CAUSING OVER 30 MINUTES DELAY IN THE CASE.

    Patient problems: Foreign Body In Patient

    MAUDE report 11154440 ↗

Other RETRACTOR devices

All RETRACTOR devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.