EXPEDIUM VERSE 199721755Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034442082), received between Nov 25, 2020 and Nov 25, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionNov 25, 2020Break; Device-Device Incompatibility; Mechanical Jam; Break; Device-Device Incompatibility; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, A PATIENT WAS TREATED WITH EXP VERSE DUE TO A DEFORMATION OF THE SPINE FROM T4-L4. DURING THE FIRST PART CORRECTION A ROD WAS PLACED AT THE LOWER PART AND THE SCREWS WERE FIXATED WITH A VERSE CORRECTION KEY THROUGH WHICH A MONO-AXIALITY WAS CREATED. THE VERSE CORRECTION KEYS WERE NOT TIGHTENED WITH A TORQUE LIMITED BUT ONLY TIGHTENED SOFTLY BY HAND TO NORMAL SOFTEN TIGHTENING OF THE ROD WITHOUT FINAL LOCKING. AFTER LOOSENING THE VERSE CORRECTION KEYS THE MONO-AXIALITY WAS NOT REVOKED AND THE MONO-BLOCK CONTINUED TO EXIST. NO DE-ROTATION WAS PERFORMED UNTIL THEN. THE L4 EXP VERSE 7MM PEDICLE SCREW BROKE THROUGH AND ALL SCREWS NEEDED TO BE REPLACED WITH BIGGER SCREWS AS THE PEDICLE FRACTURING CAUSED ALL 4 SCREWS BECOME LOCKED MONO-AXIAL CHARACTERISTICS AFTER REMOVING THE TEMPORARY ROD. THERE WAS SURGICAL DELAY OF FORTY (40) MINUTES DUE TO THE REPORTED EVENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE SCREW 7.0 X 55. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10906304 ↗