ATLAS® Cable System 826-211Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00673978047966), received between Mar 18, 2020 and Dec 21, 2023 — classified as 2 malfunctions.

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

Recent adverse event reports

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

• MalfunctionDec 21, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR FRACTURE REDUCTION. IT WAS REPORTED THAT THE CABLE WAS BROKEN. NO FRAGMENT WAS LEFT IN THE PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18380414 ↗
• MalfunctionMar 18, 2020Disconnection; Disconnection

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9849556 ↗