EXPEDIUM VERSE 299704205Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034467511), received between Apr 8, 2022 and Jul 13, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT WHEN ASSEMBLING THE FINAL TIGHTENING IN ORDER TO SET UP HER TABLE, SHE WAS UNABLE TO ATTACH THE HANDLE TO THE FACILITATOR TUBE. THE REASON THAT THIS IS THE CASE IS BECAUSE THE PROXIMAL END OF THE FACILITATOR TUBE IS SLIGHTLY DAMAGED AND THE DEVICE NEEDS TO BE CHANGED. THERE WAS NO DELAY IN THE SURGERY, DURING THE SET UP AS ANOTHER TUBE WAS SIMPLY USED TO ATTACH THE HANDLE. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) VERSE FACILITATOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15003729 ↗
• MalfunctionJun 6, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2022. IT WAS DIFFICULT TO ATTACH THE FACILITATOR A DEPLOYED DEVICE (UNK) DURING FINAL TIGHTENING. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VERSE FACILITATOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14605076 ↗
• MalfunctionApr 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PSF(TH2-SAI) FOR TREATING ADULT SPINAL DEFORMITY ON (B)(4) 2022. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THEY WERE NOT ABLE DETACH THE FACILITATOR FROM THE HANDLE DURING POSTOPERATIVE CLEANSING. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VERSE FACILITATOR. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14054181 ↗