EVOS 71174921Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00885556387344), received between Jun 18, 2020 and Feb 17, 2021 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, SCREWDRIVERS ARE WORN DOWN SO THEY DON'T FIT IN THE SCREWS PROPERLY. THIS WAS NOTICED DURING INSPECTION. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11341029 ↗
• MalfunctionJan 20, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T6 DRIVER SHAFT W/AO QC IS NOT CAPTURING SCREW AS IT USED TO. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11202777 ↗
• MalfunctionJan 20, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T6 DRIVER SHAFT W/AO QC IS NOT CAPTURING SCREW AS IT USED TO. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11202770 ↗
• MalfunctionJan 20, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T6 DRIVER SHAFT W/AO QC IS NOT CAPTURING SCREW AS IT USED TO. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11202761 ↗
• MalfunctionJan 20, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T6 DRIVER SHAFT W/AO QC IS NOT CAPTURING SCREW AS IT USED TO. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11202751 ↗
• MalfunctionJan 20, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T6 DRIVER SHAFT W/AO QC IS NOT CAPTURING SCREW AS IT USED TO. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11202726 ↗
• MalfunctionJan 20, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T6 DRIVER SHAFT W/AO QC IS NOT CAPTURING SCREW AS IT USED TO. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11202723 ↗
• MalfunctionJan 20, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T6 DRIVER SHAFT W/AO QC IS NOT CAPTURING SCREW AS IT USED TO. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11202717 ↗
• MalfunctionJan 20, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T6 DRIVER SHAFT W/AO QC IS NOT CAPTURING SCREW AS IT USED TO. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11202702 ↗
• MalfunctionJan 20, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T6 DRIVER SHAFT W/AO QC IS NOT CAPTURING SCREW AS IT USED TO. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11202700 ↗
• MalfunctionJan 20, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T6 DRIVER SHAFT W/AO QC IS NOT CAPTURING SCREW AS IT USED TO. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11202691 ↗
• MalfunctionJun 19, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT UPON INSPECTION THE BOX LABEL CODE WAS MISTAKEN. THE INSTRUMENTS INSIDE THE BOX WERE DIFFERENT, THE ACTUAL PRODUCTS INSIDE WERE 71174821, WITH BATCH LOT 18MUP0006. THERE WAS NO CASE INVOLVED. THE EVENT WAS AN OUT OF THE BOX FAILURE.

  Patient problems: No Patient Involvement

  MAUDE report 10173162 ↗
• MalfunctionJun 18, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT UPON INSPECTION THE BOX LABEL CODE WAS MISTAKEN. THE INSTRUMENTS INSIDE THE BOX WERE DIFFERENT, THE ACTUAL PRODUCTS INSIDE WERE 71174821, WITH BATCH LOT 18MUP0006. THERE WAS NO CASE INVOLVED. THE EVENT WAS AN OUT OF THE BOX FAILURE.

  Patient problems: No Patient Involvement

  MAUDE report 10171821 ↗
• MalfunctionJun 18, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT UPON INSPECTION THE BOX LABEL CODE WAS MISTAKEN. THE INSTRUMENTS INSIDE THE BOX WERE DIFFERENT, THE ACTUAL PRODUCTS INSIDE WERE 71174821, WITH BATCH LOT 18MUP0006. THERE WAS NO CASE INVOLVED. THE EVENT WAS AN OUT OF THE BOX FAILURE.

  Patient problems: No Patient Involvement

  MAUDE report 10171761 ↗