EXPEDIUM VERSE 3010-19-041Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705034561677), received between Feb 18, 2022 and Apr 4, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 21775324 ↗
• 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 21775165 ↗
• MalfunctionNov 9, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE INSTRUMENTS IN QUESTION WERE FOUND TO BE UNFIT FOR SURGERY DURING STERILE PROCESSING OF INCOMING FIELD INSPECTION. A BORESCOPE WAS RUN DOWN THE CANNULATED INSTRUMENTS AND FOUND THAT THEY FELL OUTSIDE OF THE GUIDELINES FOR USE IN SURGERY. THERE WAS NO REPORTED PATIENT INTERACTION, HOWEVER A SCHEDULED CASE HAD TO BE CANCELLED AS THE PROPER TOOLING WAS UNAVAILABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM VERSE SLEEVE NAVIGATION ENABLED INSTRUMENTS. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18103794 ↗
• MalfunctionNov 9, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE INSTRUMENTS IN QUESTION WERE FOUND TO BE UNFIT FOR SURGERY DURING STERILE PROCESSING OF INCOMING FIELD INSPECTION. A BORESCOPE WAS RUN DOWN THE CANNULATED INSTRUMENTS AND FOUND THAT THEY FELL OUTSIDE OF THE GUIDELINES FOR USE IN SURGERY. THERE WAS NO REPORTED PATIENT INTERACTION, HOWEVER A SCHEDULED CASE HAD TO BE CANCELLED AS THE PROPER TOOLING WAS UNAVAILABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM VERSE SLEEVE NAVIGATION ENABLED INSTRUMENTS. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18103793 ↗
• MalfunctionNov 9, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE INSTRUMENTS IN QUESTION WERE FOUND TO BE UNFIT FOR SURGERY DURING STERILE PROCESSING OF INCOMING FIELD INSPECTION. A BORESCOPE WAS RUN DOWN THE CANNULATED INSTRUMENTS AND FOUND THAT THEY FELL OUTSIDE OF THE GUIDELINES FOR USE IN SURGERY. THERE WAS NO REPORTED PATIENT INTERACTION, HOWEVER A SCHEDULED CASE HAD TO BE CANCELLED AS THE PROPER TOOLING WAS UNAVAILABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM VERSE SLEEVE NAVIGATION ENABLED INSTRUMENTS. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18103782 ↗
• MalfunctionNov 9, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) -2023, THE INSTRUMENTS IN QUESTION WERE FOUND TO BE UNFIT FOR SURGERY DURING STERILE PROCESSING OF INCOMING FIELD INSPECTION. A BORESCOPE WAS RUN DOWN THE CANNULATED INSTRUMENTS AND FOUND THAT THEY FELL OUTSIDE OF THE GUIDELINES FOR USE IN SURGERY. THERE WAS NO REPORTED PATIENT INTERACTION, HOWEVER A SCHEDULED CASE HAD TO BE CANCELLED AS THE PROPER TOOLING WAS UNAVAILABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM VERSE SLEEVE NAVIGATION ENABLED INSTRUMENTS. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18103777 ↗
• MalfunctionNov 9, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE INSTRUMENTS IN QUESTION WERE FOUND TO BE UNFIT FOR SURGERY DURING STERILE PROCESSING OF INCOMING FIELD INSPECTION. A BORESCOPE WAS RUN DOWN THE CANNULATED INSTRUMENTS AND FOUND THAT THEY FELL OUTSIDE OF THE GUIDELINES FOR USE IN SURGERY. THERE WAS NO REPORTED PATIENT INTERACTION, HOWEVER A SCHEDULED CASE HAD TO BE CANCELLED AS THE PROPER TOOLING WAS UNAVAILABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM VERSE SLEEVE NAVIGATION ENABLED INSTRUMENTS. THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18103774 ↗
• MalfunctionSep 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON UNKNOWN DATE. AFTER SURGERY, A REOPERATION TREATING NON-UNION WAS PERFORMED ON (B)(6), 2023. IN THE REOPERATION, THE SLEEVE CAME OFF DUE TO STRESS WHEN THE SURGEON DID ADDITIONAL TIGHTENING OF A SCREW. THE REOPERATION WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT STATUS/OUTCOME WAS STABLE. CONCOMITANT DEVICE REPORTED: UNK - SCREWS ( PART # UNKNOWN, LOT # UNKNOWN, QUANTITY). THIS REPORT IS FOR ONE (1) VERSE SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17744745 ↗
• MalfunctionMay 3, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A TLIF (L4) FOR SPONDYLOLISTHESIS ON (B)(6) 2023. THE VERSE SLEEVE IN QUESTION COULD NOT ENGAGE WITH A VERSE NAV DRIVER SHAFT. THE VERSE SLEEVE WAS REPLACED WITH ANOTHER ONE. THE RELEASE BUTTON ON THE VERSE SLEEVE WAS STIFF. IT IS ASSUMED THAT THE VERSE NAV DRIVER SHAFT COULD NOT BE ENGAGED WITH THE VERSE SLEEVE DUE TO THE STIFF RELEASE BUTTON ON THE VERSE SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VERSE SLEEVE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16861067 ↗
• MalfunctionApr 26, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVER DISSEMBLED DURING SURGERY DUE TO THE BUTTON BEING TOO FRAGILE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE VERSE SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14209714 ↗
• MalfunctionApr 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A SPINAL FUSION SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE DRIVER DISENGAGED DURING SURGERY AND THE SLEEVE FELL ONTO THE PATIENTS OPEN WOUND. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) VERSE SLEEVE DEVICE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14196307 ↗
• 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) EXPEDIUM VERSE SLEEVE NAVIGATION ENABLED INSTRUMENTS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13560963 ↗