X Ring Fixator 156-08011Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842078136478), received between Oct 29, 2025 and Oct 29, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE POLYAXIAL STRUTS WERE ASSEMBLED IN A HEXAPOD CONFIGURATION. 1 OF THE 6 STRUTS WAS COMPRESSED BY 5MM WITHOUT COMPRESSING ANY OF THE OTHER STRUTS. THE BLACK COLLET SEPARATED FROM THE BLUE STRUT BODY WHEN COMPRESSING. A 2ND STRUT WAS COMPRESSED BY 5MM CAUSING THE BODY TO SEPARATE FROM THE COLLET AGAIN. ALTHOUGH THE STRUT BODY SEPARATED FROM THE COLLET ON 2 OF THE 6 STRUTS, THE STRUTS WERE STILL STABLE AND WERE ADEQUATE TO LEAVE AS PART OF THE FRAME ASSEMBLY. THERE WAS NO IMPACT TO PATIENT, AND THERE WERE NO CONCERNS REGARDING CONSTRUCT STABILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417471 ↗