Orthex External Fixation System 810-12FRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840194411189), received between Nov 6, 2025 and Nov 12, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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.

• MalfunctionNov 12, 2025Unintended Movement; Unintended Movement

  A RIGHT HUMERUS LENGTHENING OSTEOTOMY WAS PERFORMED. ONCE THEY ATTEMPTED TO ASSEMBLE THE CONSTRUCT WITH THE ORIGINAL PINS, THEY ROLLED AWAY. THEY WERE REPLACED WITH 600-20 BOLTS, BUT THE CONSTRUCT STILL PRESENTED INSTABILITY. THE DISTRACTION AND COMPRESSION SYSTEM DID NOT MOVE EASILY ALONG THE RAIL. HOWEVER, THE DOCTOR TRIED TO ALLEVIATE THE POSITIONAL LOAD, BUT EVEN MANIPULATING THE CARRIAGE OUTSIDE THE SURGICAL FIELD, IT WAS DIFFICULT TO ADVANCE OR RETRACT. THEY TRIED TO CONTINUE WITH THE HALF PINS AND THE OSTEOTOMY. WHEN STABILIZING THE TWO FRAGMENTS, THE HALF PIN FIXATION SCREWS ROLLED, LOSING THE ALIGNMENT OF THE OSTEOTOMY, WHICH OVERLAPPED OR SHIFTED POSTERIORLY. THE TEAM DECIDED TO CHANGE THE INITIAL CONFIGURATION BY PLACING THE DISTRACTOR PROXIMALLY AND ADDING AN ADDITIONAL CLAMP ON THE DISTAL PART FOR A NEW HALF PIN TO IMPROVE THE STABILITY OF THE FRAGMENT. HOWEVER, THE TEAM WAS STILL NOT SATISFIED WITH THE RESULT. FURTHERMORE, THE INITIAL BUDGET FOR THE SURGICAL APPROACH WAS INCREASED. A REOPERATION WILL LIKELY BE NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532800 ↗
• MalfunctionNov 6, 2025Mechanical Jam; Mechanical Jam

  DR. (B)(6) NOTED THAT CARRIAGES HAD SLIDING PROBLEMS. THIS CAUSED A DELAY GREATER THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490830 ↗