EXPEDIUM VERSE 3010-19-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10705034561622), received between Jan 3, 2022 and Jun 25, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (12 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT STAFF TESTED ARRAY ON DRIVER, AND IT WOULD NOT DEPLOY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327896 ↗
• MalfunctionApr 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE CROSSNAV SCREWDRIVER TENDS TO UN-TIGHTEN ITSELF FROM THE SCREW AT SOME POINT DURING THE SCREW INSERTION. NO IMPACT ON PATIENT, NO IMPACT ON THE SURGERY. THE SURGEON IS CONCERNED WITH THE SCREWS PROPERLY ATTACHED/SECURED ONTO THE SCREWDRIVER AS DESCRIBED IN THE SURGICAL TECHNIQUE. NO SURGICAL DELAY. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21775223 ↗
• MalfunctionApr 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE CROSSNAV SCREWDRIVER TENDS TO UN-TIGHTEN ITSELF FROM THE SCREW AT SOME POINT DURING THE SCREW INSERTION. NO IMPACT ON PATIENT, NO IMPACT ON THE SURGERY. THE SURGEON IS CONCERNED WITH THE SCREWS PROPERLY ATTACHED/SECURED ONTO THE SCREWDRIVER AS DESCRIBED IN THE SURGICAL TECHNIQUE. NO SURGICAL DELAY. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21775109 ↗
• MalfunctionJan 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS WERE WORN AND STRIPPED. SURGERY WAS COMPLETED SUCCESSFULLY USING THE INSTRUMENTS, AND THERE WAS NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105961 ↗
• MalfunctionNov 20, 2024Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE REPORTED EVENT HAPPENED POST-OPERATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736158 ↗
• MalfunctionNov 19, 2024Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED STATED THAT THE EVENT OCCURRED DURING POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724398 ↗
• MalfunctionNov 19, 2024Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED STATED THAT THE EVENT OCCURRED DURING POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724300 ↗
• MalfunctionOct 30, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566443 ↗
• MalfunctionOct 4, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A POSTERIOR FUSION FOR ASD, A VERSE NAVIGATION INSTRUMENT ON RENT AT ANOTHER HOSPITAL WAS TRANSFERRED TO THIS HOSPITAL FOR USE. IN THE SURGERY, WHEN THE NURSE ATTEMPTED TO INSTALL THE VERSE NAV DRIVER SHAFT IN QUESTION, SHE WAS UNABLE TO ATTACH IT TO THE MEDTRONIC'S INSTRUMENT. SINCE THERE WAS ANOTHER VERSE NAV DRIVER SHAFT IN THE INSTRUMENT SET, THE NURSE REPLACED IT AND WAS ABLE TO ATTACH IT WITHOUT ANY PROBLEM. THIS DID NOT OCCUR WHEN THE PRODUCT WAS USED IN ANOTHER HOSPITAL. IT WAS CONSIDERED POSSIBLE THAT EITHER THE VERSE NAV DRIVER SHAFT IN QUESTION HAD BEEN DEFORMED BY SOME EFFECT, OR THAT IT WAS ORIGINALLY DEFORMED IN SHAPE. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20367330 ↗
• MalfunctionNov 8, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED ON WEDNESDAY, OCTOBER 18TH, SETS WERE DROPPED OFF FOR CASES ON FRIDAY, OCTOBER 20TH. UPON RECEIPT OF THESE SETS, THERE WERE MULTIPLE INSTRUMENTS THAT WERE DUBBED UNFIT TO BE USED IN SURGERY (PART NUMBERS OF EACH INSTRUMENT HAVE BEEN INCLUDED). SPD RAN A BOROSCOPE DOWN EACH OF THE CANNULATED INSTRUMENTS (WHICH WE AS REPS DO NOT HAVE ACCESS TO AT ANY OF OUR ACCOUNTS TO CHECK THESE OURSELVES), AND FOUND MULTIPLE INSTRUMENTS THAT FELL OUTSIDE OF THEIR GUIDELINES FOR SAFE USE IN SURGERY. SUBSEQUENTLY, I HAD TO RUN TO MULTIPLE DIFFERENT HOSPITALS AROUND DENVER TO BE ABLE TO MAKE THESE SETS COMPLETE AND USABLE. THIS PUT ME OUTSIDE OF THE GUIDELINES PUT IN PLACE BY THE VA IN TERMS OF TIMELINESS ON DROPPING OFF THE TRAYS. EVENT OCCURRED DURING STERILE PROCESSING AND FIELD INSPECTION. THERE WERE PATIENT OUTCOMES OR CONSEQUENCES. ONE OF THE TWO CASES SCHEDULED HAD TO BE CANCELLED THIS REPORT IS FOR ONE (1)EXPED VERSE NAV DRIVER - SHAFT THIS IS REPORT 10 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18096898 ↗
• MalfunctionNov 3, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PRODUCT IN QUESTION WAS RECEIVED AS A BLIND UNIT. IT WAS DISCOVERED THAT THE DEVICES WERE FOUND DEFORMED/ BENT. IT WAS DISCOVERED AFTER VISUAL INSPECTION THAT THE TIP OF THE DEVICE WAS STRIPPED/WORN. NO FURTHER INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT EXPED VERSE NAV DRIVER - SHAFT THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18064912 ↗
• MalfunctionJan 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A POSTERIOR CORRECTIVE FIXATION (THORACOLUMBAR VERTEBRAE) FOR THE AIS ON (B)(6) 2022. DURING ATTACHING THE NAVLOCK, THE SCREWDRIVER SHAFT DID NOT PASS THROUGH AND COULD NOT BE USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) EXPED VERSE NAV DRIVER - SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16196809 ↗
• MalfunctionAug 16, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVER IN QUESTION WAS FOUND TO BE UNABLE TO ENGAGE PROPERLY WITH THE NAVLOCK INTERFACE. THERE WAS NO REPORTED PATIENT INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A NAVIGATION ENABLED INSTRUMENTS EXPEDIUM VERSE DRIVER - SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15236844 ↗
• MalfunctionAug 10, 2022Break; Break

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE ON (B)(6) 2022, THE INSTRUMENT IN QUESTION BROKE DURING AN UNKNOWN PROCEDURE. THE SURGERY WAS PERFORMED USING A SIMILAR INSTRUMENT. THERE WERE NO REPORTED ADVERSE PATIENT OUTCOMES. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A NAVIGATION ENABLED INSTRUMENTS EXPEDIUM VERSE DRIVER ¿ SHAFT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15197701 ↗
• MalfunctionAug 10, 2022Break; Break

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE ON (B)(6) 2022, THE INSTRUMENT IN QUESTION BROKE DURING AN UNKNOWN PROCEDURE. THE SURGERY WAS PERFORMED USING A SIMILAR INSTRUMENT. THERE WERE NO REPORTED ADVERSE PATIENT OUTCOMES. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A NAVIGATION ENABLED INSTRUMENTS EXPEDIUM VERSE DRIVER ¿ SHAFT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15197693 ↗
• MalfunctionJun 27, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE SURGICAL TECH STRUGGLED TO ATTACH A STEALTH NAVLOCK ARRAY TO THE SCREWDRIVER SHAFT. ONCE ATTACHED, THE ARRAY WOULD NOT SPIN FREELY AS INTENDED, AND WAS DIFFICULT TO ROTATE DUE TO SIGNIFICANT FRICTION PRESENT AT THE DRIVER CONNECTION. THE SURGERY WAS ABLE TO BE COMPLETED SUCCESSFULLY. AFTER THE PROCEDURE WAS COMPLETED, THE NAVLOCK ARRAY WAS DIFFICULT TO DETACH FROM THE SCREWDRIVER. THIS REPORT IS FOR A NAVIGATION ENABLED INSTRUMENTS EXPEDIUM VERSE DRIVER ¿ SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14835720 ↗
• MalfunctionJun 1, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE DRIVER SHAFT BECAME STRIPPED DURING SCREW INSERTION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A EXPEDIUM VERSE NAV DRIVER ¿ SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569933 ↗
• MalfunctionFeb 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6)2022 DURING SPINAL FUSION WHILE ATTEMPTING TO NAVIGATE THE VERSE PEDICLE SCREW, THE HOLDING SLEEVE WOULD NOT RETAIN ON THE DRIVER. THIS WOULD NOT ALLOW SCREW TO BE NAVIGATED. NAVIGATION OF SCREW WAS DISCONTINUED AND SCREW INSERTED OVER GUIDEWIRE. PATIENT STATUS IS UNKNOWN. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE (1) NAVIGATION ENABLED INSTRUMENTS EXPEDIUM VERSE DRIVER - SHAFT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13560932 ↗
• MalfunctionFeb 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING LUMBAR FUSION SURGERY, THE ARRAY LOCKED ONTO THE DRIVER WHILE THE SCREW WAS BEING INSERTED INTO THE BONE. THE SCREW WAS BEING INSERTED WITH THE POWER HAND PIECE. SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) NAVIGATION ENABLED INSTRUMENTS EXPEDIUM VERSE DRIVER - SHAFT THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559390 ↗
• MalfunctionJan 3, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE THE TWO VERSE NAVLOCK SCREWDRIVERS WOULD NOT FIT THROUGH THE MEDTRONIC NAVLOCK ARRAY(S). THEY WERE TOO BULKY AND WOULD NOT ACTUALLY FIT THROUGH THE ARRAY. THE SCREWDRIVERS WERE NOT USED. THERE WAS A SURGICAL DELAY OF (2) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED. UNKNOWN MEDTRONIC NAVLOCK ARRAY (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS COMPLAINT INVOLVES (2) DEVICES. THIS REPORT IS FOR (1) EXPED VERSE NAV DRIVER - SHAFT. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142755 ↗
• MalfunctionJan 3, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE THE TWO VERSE NAVLOCK SCREWDRIVERS WOULD NOT FIT THROUGH THE MEDTRONIC NAVLOCK ARRAY(S). THEY WERE TOO BULKY AND WOULD NOT ACTUALLY FIT THROUGH THE ARRAY. THE SCREWDRIVERS WERE NOT USED. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED. UNKNOWN MEDTRONIC NAVLOCK ARRAY (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) EXPED VERSE NAV DRIVER - SHAFT. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142753 ↗