Drive Rail System 22-2001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817867020535), received between Nov 5, 2024 and Nov 5, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2024Connection Problem; Connection Problem

  ROTATING END CLAMP KEEPS LOOSENING, CAUSING PIN CONVERGENCE AND PREMATURE CONSOLIDATION. DR. (B)(6) TOOK THE PATIENT BACK TO OR FOR REPEAT OSTEOTOMY, TIGHTENED THE CLAMP AND A WEEK LATER THERE WAS MINIMAL LENGTH (AT 1MM/DAY DISTRACTION) AND VISIBLE RE-OCCURRENCES OF CLAMP LOOSENING/PIN CONVERGENCE ON XRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20614507 ↗