EXPEDIUM VERSE 199723435Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034403441), received between May 22, 2018 and Feb 19, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES IN QUESTION WERE RECEIVED AS PART OF A BLIND UNIT AND WERE DISCOVERED TO BE BROKEN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 4.35 X 35MM. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18730985 ↗
• MalfunctionFeb 19, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES IN QUESTION WERE RECEIVED AS PART OF A BLIND UNIT AND WERE DISCOVERED TO BE BROKEN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 4.35 X 35MM. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18730982 ↗
• MalfunctionFeb 19, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES IN QUESTION WERE RECEIVED AS PART OF A BLIND UNIT AND WERE DISCOVERED TO BE BROKEN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 4.35 X 35MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18730980 ↗
• InjuryApr 14, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON HAD TO REVISE THE IMPLANT BECAUSE HE FOUND A BROKEN SCREW. IT WAS NECESSARY FOR THE SURGEON TO DO A NEW SURGERY TO OVERHAUL THE SYSTEM. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 4.35X35. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16745051 ↗
• InjuryApr 14, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON HAD TO REVISE THE IMPLANT BECAUSE HE FOUND A BROKEN SCREW. IT WAS NECESSARY FOR THE SURGEON TO DO A NEW SURGERY TO OVERHAUL THE SYSTEM. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 4.35X35 THIS IS REPORT 3 OF 4 FOR COMPLAINT: (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16744880 ↗
• InjuryMay 22, 2018Break; Break

  PLANNED REVISION: POSTERIOR SPINAL FUSION, (B)(6) PRIVATE. SURGEON REPORTED THAT ALL OF THE SCREWS HAS BROKEN INSIDE THE PEDICLE. AN X-RAY IMAGE IS TO BE SENT TO JNJ REPRESENTATIVE. MORE TO FOLLOW AS AND WHEN SURGEON PROVIDES. PATIENT INITIALS: (B)(6).

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7532793 ↗