MODULAR RAIL SYSTEM 71934656Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556235843), received between Dec 22, 2020 and Feb 16, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE SWIVEL CLAMP COULD NOT BE FIXED IN THE DESIRED POSITION. IT IS UNKNOWN IF THE PATIENT SUFFER ANY SURGICAL INTERVENTION DUE TO THIS MALFUNCTION. NO DELAY OR THE USE A BACK UP HAS BEEN CONFIRMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11330953 ↗
• InjuryJan 19, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT AFTER A PATIENT UNDERWENT A PROCESS TO CORRECT THE AXIS, THE CLAMP PLACED AND PROTECTED WITH WIRES DID NOT WORK. THE PATIENT WENT THROUGH A MEDICAL INTERVENTION SO THE DOCTOR MADE A NEW SECURE CONSTRUCT USING ILIZAROV PARTS. THE AXIS CORRECTION WILL BE COMPLETED IN 2-3 MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11197012 ↗
• InjuryDec 22, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A REPLACEMENT OF "STANDARD" CLAMP TO SWIVEL CLAMP SURGERY, THE CLAMP OF THE MODULAR RAIL SYSTEM COULD NOT BE FIXED IN THE DESIRED POSITION, IT DID NOT LOCK. THEN, A CHANGE IN SURGICAL TECHNIQUE WAS REPORTED SINCE THE CLAMP WAS FIXED DURING THE PROCEDURE BY USING WIRES. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE CONCLUDED WITH THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11056346 ↗