EXPEDIUM VERSE 199721750Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034442099), received between Sep 4, 2018 and Jan 4, 2024 — classified as 3 injuries, 4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: IMPLANT FAILURE COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM VERSE PRODUCTS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18446368 ↗
• MalfunctionSep 14, 2020Material Twisted/Bent; Migration; Material Twisted/Bent; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 THAT THE PATIENT UNDERWENT FOR A PROCEDURE OF CORRECTION KEY ROD LOCK. DURING THE PROCEDURE, THE WHOLE OF CORRECTION KEY WAS PUSHED BACK WITH TICK SOUND. THE EXPEDIUM VERSE CORRECTION KEY SET SCREW AND THE SCREW AND THE SCREW HEAD GOT WEAR AND TEAR IN THE FINAL STEP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES DELAY. ALL GENERATED FRAGMENTS ARE REMOVED WITHOUT ANY INTERVENTION. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN TIGHTENER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1)5.5 EXP VERSE SCREW 7.0 X 50. THIS IS REPORT 1 OF 10 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10532188 ↗
• MalfunctionSep 14, 2020Material Twisted/Bent; Migration; Material Twisted/Bent; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 THAT THE PATIENT UNDERWENT FOR A PROCEDURE OF CORRECTION KEY ROD LOCK. DURING THE PROCEDURE, THE WHOLE OF CORRECTION KEY WAS PUSHED BACK WITH TICK SOUND. THE EXPEDIUM VERSE CORRECTION KEY SET SCREW AND THE SCREW AND THE SCREW HEAD GOT WEAR AND TEAR IN THE FINAL STEP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES DELAY. ALL GENERATED FRAGMENTS ARE REMOVED WITHOUT ANY INTERVENTION. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN TIGHTENER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1)5.5 EXP VERSE SCREW 7.0 X 50. THIS IS REPORT 4 OF 10 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10532183 ↗
• MalfunctionJun 22, 2020Break; Break

  IT WAS REPORTED THAT DURING A SPINAL FUSION FOR A L1 BURST FRACTURE ON (B)(6) 2020, THE SURGEON WAS BREAKING THE TABS OFF A VERSE SCREW AND IN DOING SO, A PART OF THE SCREW WAS CHIPPED OFF. THE SURGEON PLACED SCREWS IN LEVELS T11 L2. SCREWS WERE PLACED SUCCESSFULLY. SPINAL RODS WERE CONTOURED AND PLACED INTO THE SCREW HEADS. SET SCREWS WERE PLACED OVER THE RODS SUCCESSFULLY. FINAL TIGHTENING OF THE SET SCREWS WAS SUCCESSFUL. THE SURGEON WENT TO BREAK THE EXTENDED TABS OFF THE SCREWS, AND ONE SCREW CHIPPED WHILE BREAKING OFF A TAB. THE SURGEON THEN REMOVED THE SET SCREW FROM THAT VERSE SCREW AND REPLACED IT WITH A NEW SCREW. THE CHIPPED PIECE OF SCREW WAS REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF TWENTY (20) MINUTES. THE PATIENT WAS NOT HARMED. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 7.0 X 50. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 10180942 ↗
• MalfunctionDec 11, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE TOP-NOTCH PART OF EXPEDIUM VERSE SCREW HEAD WAS BROKEN WHEN THE SURGEON TRIED TO FINALIZE FOR LOCKING THE CORRECTION KEY CAP WITH FACILITATOR. SURGICAL DELAY OF THIRTY MINUTES WAS REPORTED. THE SURGEON REMOVED THE SCREW AND INSERTED A NEW ONE. CONCOMITANT DEVICE REPORTED: UNKNOWN CORRECTION KEY CAP (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE SCREW 7.0 X 50. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9453257 ↗
• InjuryJul 24, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE ROD THAT WAS BROKEN BILATERALLY AND THE DISTAL SCREWS WERE LOOSENED. BROKEN ENDS OF ROD CATALOG # 1797-62-480, VERSE SCREW, 1997-21-750 X QTY 1, VERSE SCREW 1997-21-745 X QTY 1 AND 9.0 X 90 MM SAI SCREWS 1797-04-990 X QTY 2 WERE ALL REMOVED TO REVISE. A 12.0 X 100 MM SCREW, 1797-12-399 WAS REMOVED WITH PLIERS DUE TO THE FIRST OF TWO SCREWDRIVER TIPS BREAKING. THIS SCREW WAS NOT RECOVERED TO RETURN. THERE WERE NO FRAGMENTS GENERATED. IT IS UNKNOWN IF THERE WERE SURGICAL DELAY. THE PATIENT AND PROCEDURE OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8821589 ↗
• InjurySep 4, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD A L2-S1 POSTERIOR SPINAL FUSION IN (B)(6) 2018 WITH DEPUY SYNTHES SPINE "VERSE". THE PATIENT WAS FOUND TO HAVE HARDWARE RELATED ISSUES DISCOVERED ON PATIENT FOLLOWUP. THE RIGHT L2 SCREW ON XRAY APPEARS TO HAVE CUT THROUGH THE PEDICLE CRANIALLY, AND THE INITIALED SET SCREW WAS FREE FLOATING. ON (B)(6) DR. (B)(6) PERFORMED THE REVISION. SHE REMOVED ALL THE SET SCREWS. AS MENTIONED, THE RIGHT L2 SET SCREW WAS FREE FLOATING. SHE COMMENTED THAT THE BILATERAL L3 SETS SCREWS AND LEFT L2 SET SCREW WERE VERY LOOSE. SHE REMOVED THE RODS. DR. (B)(6) ALSO FOUND THAT THE RIGHT S1 SCREW HAD BROKEN RIGHT BELOW THE SCREW HEAD (VERSE 7.0 X 50MM SCREW). SHE WAS ABLE TO GET THE SCREW SHAFT OUT AND REPLACED THE SCREW WITH AN EXPEDIUM POLY SCREW. SHE ALSO REPLACED THE L2 SCREWS (UNKNOWN SIZE) AND ALSO EXTENDED THE CONSTRUCT CRANIAL TO L1 AND CAUDAL TO THE ILIUM. THE ROD PART # REMOVED IS UNKNOWN. DR. (B)(6) THEN CONTOURED RODS AND CONNECTED THEM. SHE SUCCESSFULLY COMPLETED THE PROCEDURE. WEIGHT AND HEIGHT ARE UNKNOWN. NO OTHER INFORMATION IS AVAILABLE. NO CUSTOMER RESPONSE NEEDED. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7842822 ↗