EXPEDIUM VERSE 199721740Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034442112), received between Oct 3, 2017 and Sep 13, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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.

• MalfunctionSep 13, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 WHILE USING THE SCREW, THE BLUE BATH CAME OFF. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 7.0 X 40MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12459958 ↗
• MalfunctionApr 14, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR SURGERY. DURING THE SURGERY, WHEN ATTEMPTING FINAL TIGHTENING WHICH WAS NOT POSSIBLE DUE TO THE DAMAGE. THE CK DAMAGED THE THREAD ON THE PEDICLE SCREWS WHILST. IT WAS ON THE APEX OF AN ACUTE ADULT DEGEN CURVE WITH 3 ALIFS ALREADY IN PLACE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH DELAY. THE PATIENT WAS GOOD. CONCOMITANT DEVICE REPORTED: UNKNOWN TIGHTENER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 5.5 EXP VERSE SCREW 7.0 X 40. THIS REPORT IS 1 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11667252 ↗
• MalfunctionAug 18, 2020Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON (B)(6) 2020, THE THREADS ON AN 7.0X40MM EXPEDIUM VERSE SCREW AT LEFT L5 CAME DISLODGED AND PREVENTED THE VERSE CORRECTION KEY FROM THREADING DOWN ENTIRELY MAKING IT IMPOSSIBLE TO FINAL TIGHTEN THE SETSCREW. THE SCREW WAS REMOVED AND REPLACED WITH ANOTHER 7.0X40MM EXPEDIUM VERSE SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF TEN (10) MINUTES. THE PATIENT STATUS/OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN TIGHTENER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). UNKNOWN LOCKING/SET SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE SCREW 7.0 X 40. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10421091 ↗
• MalfunctionOct 3, 2017Torn Material; Torn Material

  THE SCREW WAS INSERTED WITHOUT NO PROBLEM HOWEVER WHEN THE ROD WAS PLACED AND CORRECTION MANEUVER CARRIED OUT THE SURGEON COULD NOT GET A LOCKING CAP INTO THE HEAD OF THE SCREW. WE TRIED 2 LOCKING CAPS AND THIS STILL DID NOT SIT PROPERLY AND UNFORTUNATELY RESULTED IN THE REST OF THE LOCKING CAPS BEING REMOVED AND ROD REMOVED FOR HIM TO HAVE TO REPLACE THE SCREW. I HAVE LOOKED AT THE SCREW AND IT LOOKS IT WAS DAMAGED. PLEASE CAN THIS BE INVESTIGATED AND A REPLACEMENT SENT OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6910275 ↗