Reference Star Iop Imaging 19145-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056481004620), received between Nov 8, 2016 and Nov 8, 2016.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K092467); they may or may not involve this specific model.

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.

• Nov 8, 2016Mechanical Problem; Improper or Incorrect Procedure or Method; Mechanical Problem; Improper or Incorrect Procedure or Method

  A MINIMALLY INVASIVE SPINE SURGERY FOR AN ODONTOID SCREW PLACEMENT WAS PLANNED TO BE PERFORMED WITH THE AID OF BRAINLAB NAVIGATION SYSTEM SPINE & TRAUMA 3D 2.5. DURING THE PROCEDURE THE SURGEON: - FIXATED THE PATIENT'S HEAD IN A THIRD PARTY HEAD CLAMP AND ATTACHED THE NAVIGATION REFERENCE ARRAY TO THE HEAD CLAMP. - PERFORMED AN AUTOMATIC IMAGE REGISTRATION (MATCHING OF VIRTUAL DISPLAY OF PATIENT IMAGE DATA AND ACTUAL PATIENT ANATOMY) IN COMBINATION WITH AN AIRO CT SCANNER. - ROTATED THE PATIENT TABLE BY 90 DEGREE AND MOVED THE NAVIGATION CAMERA FROM THE FOOT TO THE HEAD SIDE OF THE TABLE. - SWITCHED THE REFERENCE ARRAY FROM UNSTERILE TO STERILE. - USED THE AID OF NAVIGATION TO DETERMINE THE ACCORDING ENTRY POINT AND ANGLE OF THE ODONTOID SCREW AND PLACED THE K-WIRE WITH THE AID OF NAVIGATION. - PLACED THE SCREW WITHOUT THE AID OF NAVIGATION. - PERFORMED A VERIFICATION SCAN WITH AN AIRO CT SCANNER TO CONFIRM CORRECT PLACEMENT OF THE SCREW AND DETECTED THAT THE SCREW PLACEMENT WAS NOT AS INTENDED. - REPLACED THE SCREW WITHOUT THE AID OF NAVIGATION. ACCORDING TO THE HOSPITAL, THE SURGERY COULD BE COMPLETED SUCCESSFULLY AND THERE WERE NO NEGATIVE CLINICAL EFFECTS FOR THE PATIENT DUE TO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6085379 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092467. One submission often covers many models, so check the product and lot details in each record.

• Z-0056-2021 · Aug 31, 2020 · Terminated
  Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided l
• Z-0598-2016 · Apr 22, 2013 · Terminated
  Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative imag