N/A 8900-100-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327503265), received between Feb 3, 2023 and Apr 25, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2024Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement

  IT WAS REPORTED THAT WHEN USING THE SPINE GUIDANCE SOFTWARE, THE ACCURACY WAS OFF BY 2-3 MILLIMETERS WHICH MADE NAVIGATION AND SCREW PLACEMENT DIFFICULT FOR THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19187718 ↗
• MalfunctionApr 25, 2024Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement

  IT WAS REPORTED THAT WHEN USING THE SPINE GUIDANCE SOFTWARE, THE ACCURACY WAS OFF BY 2-3 MILLIMETERS WHICH MADE NAVIGATION AND SCREW PLACEMENT DIFFICULT FOR THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19187715 ↗
• MalfunctionNov 27, 2023Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement

  PER THE CUSTOMER, THE AUTOMATIC REGISTRATION NOT ACCURATE ON Q SYSTEM WHEN USED WITH THE ZIEHM C ARM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208661 ↗
• MalfunctionSep 11, 2023Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement

  PER THE CUSTOMER, DURING AN EM REGISTRATION, POINTS WERE PICKED THAT WERE ROUGHLY 2MM AVERAGE AND INDICATED IT WAS NECESSARY TO SURFACE TRACE. THEY RESTARTED WITH 130 POINTS, THIS WAS NOT ENOUGH AND ACCURACY WAS STILL OFF. AFTER FURTHER SURFACE TRACING ACCURACY WAS STILL OFF. THE CUSTOMER SURFACE TRACED UP TO ALMOST 500 POINTS AND ACCURACY WAS STILL OFF. THE CUSTOMER THEN REPICKED POINTS AND PROCEEDED AGAIN WITH REGISTRATION AND SURFACE TRACING WHERE ACCURACY WAS ACCEPTABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719636 ↗
• MalfunctionAug 9, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, DURING A PROCEDURE, DURING THE REGISTRATION PROCESS THERE WAS UP TO 2 MM DEVIATION, TWO REGISTRATION POINTS WERE DROPPED DUE TO HIGH DEVIATIONS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17490987 ↗
• MalfunctionMay 16, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE SELECTION PROCESS CHANGED TO UNINTENDED POINTS DURING THE REGISTRATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16940636 ↗
• MalfunctionFeb 27, 2023Display or Visual Feedback Problem; Incorrect Measurement; Improper or Incorrect Procedure or Method; Display or Visual Feedback Problem; Incorrect Measurement; Improper or Incorrect Procedure or Method

  PER THE CUSTOMER, AUTO-SEGMENTATION WAS NOT AVAILABLE AFTER THE AIRO SCAN AS THE LICENSING FOR IT WAS NOT IMPLEMENTED. WHILE NAVIGATING SCREWS, THERE APPEARED TO BE MOVEMENT ON THE SCREEN/IMAGES WITHOUT ANYTHING TOUCHING THE SCREEN. AFTER A CONFIRMATION SPIN WITH THE AIRO, 2 OUT OF 8 SCREWS WERE ANGLED MORE CRANIAL DESPITE FOLLOWING OUR PREPLANNED TRAJECTORY. THE TWO SCREWS WERE REVISED AFTER THE CONFIRMATION SCAN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444838 ↗
• MalfunctionFeb 3, 2023Incorrect Measurement; Intermittent Program or Algorithm Execution; Incorrect Measurement; Intermittent Program or Algorithm Execution

  PER THE CUSTOMER, AFTER RE-SPINNING THE ZIEHM C-ARM DUE TO THE SURGICAL STAFF BUMPING THE PATIENT TRACKER DURING THE CASE AND CAUSING ACCURACY PROBLEMS, THE LOCAL CORRELATION FOR THE PREOPERATIVE L1 VERTEBRAE FROM CT1 WAS UNABLE TO BE MERGED WITH CT3. THE Q-GUIDANCE SOFTWARE WOULD NOT ALLOW CT1 TO BE MERGED WITH CT3 AT THIS LEVEL, ONLY ALLOWING CT1 TO BE MERGED WITH THE PREVIOUS CT2. THE Q GUIDANCE SOFTWARE WOULD ALLOW MERGING OF OTHER LOCAL CORRELATIONS TO THE NEW SCAN. PER THE CLINICAL SPECIALIST THE PROCEDURE WAS ABORTED FOLLOWING OTHER PROBLEMS IN THE OPERATING ROOM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY TWO DAYS LATER WITH A DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16294696 ↗