NA 392.961Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982198877), received between Sep 14, 2018 and Sep 14, 2018 — classified as 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. 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.

• MalfunctionSep 14, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2018, THE SWIVEL LOCKING SCREW ON THE ADJUSTABLE LARGE FIXATOR CAME OFF, LEAVING THE DEVICE IN THREE (3) PIECES. FRAGMENTS WERE EASILY REMOVED. A LARGE EXTERNAL FIXATOR WAS USED TO STABILIZE THE CONSTRUCT AND COMPLETE THE PROCEDURE SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 25 MINUTES. EVALUATION OF THE RETURNED DEVICE REVEALED THE PARALLEL PIN PORTION OF THE DEVICE IS BROKEN. THIS REPORT IS FOR ONE (1) ADJUSTABLE LARGE FIXATOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7876687 ↗