EXPEDIUM VERSE 199723535Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034403274), received between May 22, 2018 and Jul 23, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 23, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE INSERTER COULD NOT BE ENTERED CORRECTLY INTO THE CORRECTION KEY AND SLIPPED DURING THE FINAL TIGHTENING. THIS DAMAGED THE THREAD OF THE SCREW HEAD. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH REPLACEMENT SCREW AND SET SCREWS. CONCOMITANT DEVICES: UNKNOWN TORQUE HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2). UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN)). THIS REPORT IS FOR (1) 5.5 EXP VERSE FEN SCR 5.0X35. THIS IS REPORT 14 OF 14 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12219401 ↗
• MalfunctionJul 23, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE INSERTER COULD NOT BE ENTERED CORRECTLY INTO THE CORRECTION KEY AND SLIPPED DURING THE FINAL TIGHTENING. THIS DAMAGED THE THREAD OF THE SCREW HEAD. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH REPLACEMENT SCREW AND SET SCREWS. CONCOMITANT DEVICES: UNKNOWN TORQUE HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2). UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 5.0X35. THIS IS REPORT 13 OF 14 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12219084 ↗
• MalfunctionJul 23, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021 THAT THE INSERTER COULD NOT BE ENTERED CORRECTLY INTO THE CORRECTION KEY AND SLIPPED DURING THE FINAL TIGHTENING. THIS DAMAGED THE THREAD OF THE SCREW HEAD. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH REPLACEMENT SCREW AND SET SCREWS. CONCOMITANT DEVICES: UNKNOWN TORQUE HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2) UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN)) THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 5.0X35. THIS IS REPORT 4 OF 14 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12218391 ↗
• InjuryMay 22, 2018Break; Break

  PLANNED REVISION: POSTERIOR SPINAL FUSION, (B)(6). 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. (B)(6).

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7532976 ↗