XVS Headset IPD-60 Clear Display AHMD601WLTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07290113780132), received between Dec 14, 2021 and Aug 3, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2022Use of Device Problem; Use of Device Problem

  A TOTAL OF 4 SCREWS WERE INSTRUMENTED: LEFT AND RIGHT L1 / LEFT AND RIGHT T11 (SCREWS WERE NOT PLACED AT T12 DUE TO THE TRAUMA BURST FRACTURE). LL1 SCREW WAS THE FIRST SCREW INSTRUMENTED FOLLOWED BY RL1. BOTH SCREWS WERE INSTRUMENTED USING THE ATEC SINGLE-STEP DRIVE, 45MM K-WIRE IN THE DRIVER, 4.5 X 45MM SCREWS, AND A POWER T-HANDLE ADAPTOR. T11 WAS INSTRUMENTED NEXT USING THE ATEC SINGLE STEP DRIVER, 45MM K-WIRE LOADED IN THE DRIVER, 6.5 X 45MM SCREWS, AND A REGULAR T-HANDEL ADAPTOR TO ADVANCE THE SCREW. ALL SCREWS STEMMED GREATER THAN 20 ON THE NEUROMONITORING. WHILE REVIEWING THE CONFORMATION SPIN ON THE O-ARM TOWER IT WAS NOTED THAT THE LEFT L1 SCREW HAD BREACHED THE CENTRAL CANAL. THE OTHER 3 SCREWS WERE CONFIRMED TO BE IN ACCEPTABLE PLACEMENT. L1 SCREW WAS REMOVED AND RE-DIRECTED MORE LATERALLY USING XVS NAVIGATION AND THE ORIGINAL REGISTRATION MATRIX. SCREW STEMMED ABOVE 20 ON NEUROMONITORING. A CONFORMATION SPIN THAT WAS DONE AFTER THE RE-DIRECTION OF THE LEFT L1, CONFIRMED ACCURATE PLACEMENT. WHILE INVESTIGATING THIS CASE, 3 POSSIBLE CAUSES OF INACCURACIES DURING SUCH A PROCEDURE WERE RAISED: INACCURATE REGISTRATION: INACCURATE REGISTRATION CAN RESULT FROM MOVEMENT OF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15155159 ↗
• InjuryJul 13, 2022Use of Device Problem; Use of Device Problem

  A TOTAL OF 4 SCREWS WERE INSTRUMENTED: LEFT AND RIGHT L1 / LEFT AND RIGHT T11 (SCREWS WERE NOT PLACED AT T12 DUE TO THE TRAUMA BURST FRACTURE). LL1 SCREW WAS THE FIRST SCREW INSTRUMENTED FOLLOWED BY RL1. BOTH SCREWS WERE INSTRUMENTED USING THE ATEC SINGLE-STEP DRIVE, 45 MM K-WIRE IN THE DRIVER, 4.5 X 45 MM SCREWS, AND A POWER T-HANDLE ADAPTOR. T11 WAS INSTRUMENTED NEXT USING THE ATEC SINGLE STEP DRIVER, 45 MM K-WIRE LOADED IN THE DRIVER, 6.5 X 45 MM SCREWS, AND A REGULAR T-HANDEL ADAPTOR TO ADVANCE THE SCREW. ALL SCREWS STEMMED GREATER THAN 20 ON THE NEUROMONITORING. WHILE REVIEWING THE CONFORMATION SPIN ON THE O-ARM TOWER IT WAS NOTED THAT THE LEFT L1 SCREW HAD BREACHED THE CENTRAL CANAL. THE OTHER 3 SCREWS WERE CONFIRMED TO BE IN ACCEPTABLE PLACEMENT. L1 SCREW WAS REMOVED AND RE-DIRECTED MORE LATERALLY USING XVS NAVIGATION AND THE ORIGINAL REGISTRATION MATRIX. SCREW STEMMED ABOVE 20 ON NEUROMONITORING. A CONFORMATION SPIN THAT WAS DONE AFTER THE RE-DIRECTION OF THE LEFT L1, CONFIRMED ACCURATE PLACEMENT. WHILE INVESTIGATING THIS CASE, 3 POSSIBLE CAUSES OF INACCURACIES DURING SUCH A PROCEDURE WERE RAISED: INACCURATE REGISTRATION: INACCURATE REGISTRATION CAN RESULT FROM MOVEMENT OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15001120 ↗
• InjuryDec 30, 2021Use of Device Problem; Use of Device Problem

  LEVELS L3-L5 WERE INSTRUMENTED IN AN OPEN PROCEDURE OF A HIGH BMI PATIENT (39.4). INSTRUMENTATION STARTED ON LEFT TOP TO LEFT BOTTOM. ONCE THE SURGEON GOT TO THE RIGHT SIDE OF THE PATIENT, HE WAS HAVING DIFFICULTIES WITH ALL THE PATIENT'S SOFT TISSUE AND ODD PEDICLES AND DECIDED TO ABORT AND COMPLETE THE PROCEDURE WITH THE STEALTHSTATION. IN ORDER TO RE-REGISTER WITH THE STEALTHSTATION, A SECOND SPIN WAS PERFORMED. THE SURGEON NOTICED IN THE SCAN THAT L4 SCREW WAS PLACED INFERIORLY TO THE PEDICLE, WHEREAS DURING THE CASE, THE SYSTEM DISPLAYED THE POSITION OF THE SCREW IN THE PEDICLE. THE SCREW WAS REMOVED AND REPOSITIONED. THE INVESTIGATION BY THE COMPANY REVEALED THAT THE CALIBRATION OF THE SCREWDRIVER WAS NOT PERFORMED AS INDICATED IN THE XVS USER MANUAL. IN THE FIRST TWO ATTEMPTS TO CALIBRATE THE SCREWDRIVER ACCORDING TO THE XVS USER MANUAL INSTRUCTIONS, THE SYSTEM NOTIFIED THE USER THAT THE SCREWDRIVER IS TOO BENT AND DID NOT ENABLE THE SUCCESSFUL COMPLETION OF CALIBRATION. AT THIS POINT, THE SCREWDRIVER WAS CALIBRATED USING THE CALIBRATION METHOD THAT IS DESIGNED FOR FIXED INSTRUMENTS AND NOT SWIVELED INSTRUMENTS. CALIBRATION WAS COMPLETED, HOWEVER, THE RISK IN THIS SYSTEM MIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13117222 ↗
• InjuryDec 14, 2021Use of Device Problem; Use of Device Problem

  LEVELS L3-L5 WERE INSTRUMENTED IN AN OPEN PROCEDURE OF A HIGH BMI PATIENT (39.4). INSTRUMENTATION STARTED ON LEFT TOP TO LEFT BOTTOM. ONCE THE SURGEON GOT TO THE RIGHT SIDE OF THE PATIENT, HE WAS HAVING DIFFICULTIES WITH ALL THE PATIENT'S SOFT TISSUE AND ODD PEDICLES AND DECIDED TO ABORT AND COMPLETE THE PROCEDURE WITH THE STEALTHSTATION. IN ORDER TO RE-REGISTER WITH THE STEALTHSTATION, A SECOND SPIN WAS PERFORMED. THE SURGEON NOTICED IN THE SCAN THAT L4 SCREW WAS PLACED INFERIORLY TO THE PEDICLE, WHEREAS DURING THE CASE, THE SYSTEM DISPLAYED THE POSITION OF THE SCREW IN THE PEDICLE. THE SCREW WAS REMOVED AND REPOSITIONED. THE INVESTIGATION BY THE COMPANY REVEALED THAT THE CALIBRATION OF THE SCREWDRIVER WAS NOT PERFORMED AS INDICATED IN THE XVS USER MANUAL. IN THE FIRST TWO ATTEMPTS TO CALIBRATE THE SCREWDRIVER ACCORDING TO THE XVS USER MANUAL INSTRUCTIONS, THE SYSTEM NOTIFIED THE USER THAT THE SCREWDRIVER IS TOO BENT AND DID NOT ENABLE THE SUCCESSFUL COMPLETION OF CALIBRATION. AT THIS POINT, THE SCREWDRIVER WAS CALIBRATED USING THE CALIBRATION METHOD THAT IS DESIGNED FOR FIXED INSTRUMENTS AND NOT SWIVELED INSTRUMENTS. CALIBRATION WAS COMPLETED, HOWEVER, THE RISK IN THIS SYSTEM MIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12998240 ↗