EXPEDIUM VERSE 199723735SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034444529), received between Dec 9, 2020 and Nov 3, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Slipped” (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 16, 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.

• InjuryNov 3, 2021Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE FUSION PROCEDURE (TH11-L4) WAS PERFORMED WITH THE VERSE FENESTRATED SCREW AND THE VERSE PRIME SYSTEM. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUE. ON AN UNKNOWN POSTOPERATIVE DATE, IT WAS FOUND THAT THE VERSE FENESTRATED SCREW HAD BACKED OUT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 7.0 X 35MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12748560 ↗
• InjuryDec 9, 2020Device Slipped; Device Slipped

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE OF 2020, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE DUE TO IMPLANT COMPLICATIONS. THE CEMENT WAS NOT INTACT. PART WAS LEFT INSITU - OTHER PART AROUND SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS OSTEOPENIA /OSTEOPOROTIC. THIS COMPLAINT INVOLVES SIX (6) DEVICES. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). BBRAUN SETSCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR (1) 5.5 EXP VERSE FEN SCR 7.0X35. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10979373 ↗
• InjuryDec 9, 2020Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, A THIRD REVISION SURGERY WAS PERFORMED DUE TO SCREWS BEING LOOSE IN THE PATIENT. THE ROD WAS REUSED, PREVIOUS BBRAUN SET SCREWS WERE REUSED, AND NEW SET SCREWS WERE PLACED. THE CEMENT WAS NOT INTACT. PART WAS LEFT INSITU - OTHER PART AROUND SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS OSTEOPAENIC/OSTEOPOROTIC. THE ORIGINAL SURGERY WAS PERFORMED IN 2012. THE SECOND REVISION SURGERY WAS PERFORMED IN 2018. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). BBRAUN SETSCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 7.0X35. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10979370 ↗