EXPEDIUM VERSE 299704230Recalls & reported problems
Medos International Sàrl · EXPEDIUM VERSE SPINE SYSTEM INSERTER/TIGHTENER X25 · Class 1
All models of EXPEDIUM VERSE (90)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medos Expedium Verse spine system inserter appears in 873 adverse event reports, with 8 injuries and no deaths. Many describe the tool bending, chipping or breaking during surgery, with some mentioning tips breaking inside patients. Several reports note no patient harm or surgical delay. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 875
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 875 adverse event reports that list this exact device (DI 10705034467634), received between Aug 21, 2017 and Sep 22, 2026 — classified as 8 injuries, 867 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (669 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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent669
- Break89
- Device-Device Incompatibility58
- Material Deformation41
- Mechanical Problem24
- Material Integrity Problem15
- Material Split, Cut or Torn7
- No Apparent Adverse Event4
Patient problems
- No Clinical Signs, Symptoms or Conditions755
- No Consequences Or Impact To Patient97
- Insufficient Information13
- Not Applicable9
- Foreign Body In Patient7
- No Known Impact Or Consequence To Patient5
- No Patient Involvement3
- No Code Available2
Recent adverse event reports
The 25 most recent of 875 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859485 ↗MalfunctionSep 22, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859484 ↗MalfunctionSep 22, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859481 ↗MalfunctionSep 11, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741439 ↗MalfunctionSep 11, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741407 ↗MalfunctionSep 11, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741205 ↗MalfunctionSep 11, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741201 ↗MalfunctionAug 27, 2026Break
It was reported that X25 FINAL TIGHTENER, VERSE X25 INSERTER/TIGHTENER, and FINAL TIGHTENER X20 chipped too quickly and broke during use, including reports that tips broke inside the patient. The event was identified pre-operatively/intraoperatively during use. No patient harm or significant delay was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50479512 ↗MalfunctionAug 27, 2026Break
It was reported that X25 FINAL TIGHTENER, VERSE X25 INSERTER/TIGHTENER, and FINAL TIGHTENER X20 chipped too quickly and broke during use, including reports that tips broke inside the patient. The event was identified pre-operatively/intraoperatively during use. No patient harm or significant delay was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50479510 ↗MalfunctionJun 25, 2026Material Twisted/Bent
IT WAS REPORTED ON JUNE 4, 2026 THE FINAL TIGHTENER DRIVER WAS STRIPPED. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25630002 ↗MalfunctionJun 25, 2026Material Twisted/Bent
IT WAS REPORTED ON JUNE 4, 2026 THE FINAL TIGHTENER DRIVER WAS STRIPPED. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25629971 ↗MalfunctionJun 25, 2026Material Twisted/Bent
IT WAS REPORTED ON JUNE 4, 2026 THE FINAL TIGHTENER DRIVER WAS STRIPPED. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25629935 ↗MalfunctionJun 25, 2026Material Twisted/Bent
IT WAS REPORTED ON JUNE 4, 2026 THE FINAL TIGHTENER DRIVER WAS STRIPPED. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25629910 ↗MalfunctionJun 25, 2026Material Twisted/Bent
IT WAS REPORTED ON (B)(6) 2026 THE FINAL TIGHTENER DRIVER WAS STRIPPED. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25629862 ↗MalfunctionJun 25, 2026Material Twisted/Bent
IT WAS REPORTED ON (B)(6) 2026 THE FINAL TIGHTENER DRIVER WAS STRIPPED. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25629822 ↗MalfunctionJun 25, 2026Material Twisted/Bent
IT WAS REPORTED ON (B)(6) 2026 THE FINAL TIGHTENER DRIVER WAS STRIPPED. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25629684 ↗MalfunctionJun 5, 2026Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT DURING A PROCEDURE, THE INSERTER DRIVER SHAFT (BOTH TIPS) WERE WORN AND UNABLE TO LOAD CORRECTLY. THE TRANSVERSE CONNECTER DRIVER (X2 DRIVER TIP) WERE WORN AND UNABLE TO RIP THE SCREW CORRECTLY. THERE WAS NO PATIENT IMPACTS AND NO ADVERSE INCIDENT. THERE WAS A MINIMAL DELAY TO SURGERY. DEVICES WERE DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25415124 ↗MalfunctionMay 27, 2026Material Twisted/Bent
THE TIP OF THE SCREWDRIVER IS WORN DOWN DUE TO NORMAL USE OF TIGHTENING. NO SURGICAL DELAY. NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25304015 ↗MalfunctionMay 27, 2026Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THAT FINAL TIGHTENER STRIPPED. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25299846 ↗MalfunctionMay 14, 2026Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2026 THE FINAL TIGHTENER WAS STRIPPED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO GENERATION OF FRAGMENTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25177004 ↗MalfunctionMay 14, 2026Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2026 THE FINAL TIGHTENER WAS STRIPPED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO GENERATION OF FRAGMENTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25177000 ↗MalfunctionMay 14, 2026Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2026 THE FINAL TIGHTENER WAS STRIPPED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO GENERATION OF FRAGMENTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25176993 ↗MalfunctionMay 14, 2026Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6), 2026 THE FINAL TIGHTENER WAS STRIPPED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO GENERATION OF FRAGMENTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25176969 ↗MalfunctionMay 14, 2026Material Twisted/Bent
IT WAS REPORTED THAT ON APR 29, 2026 THE FINAL TIGHTENER WAS STRIPPED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO GENERATION OF FRAGMENTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25176942 ↗MalfunctionMay 14, 2026Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2026 THE FINAL TIGHTENER WAS STRIPPED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO GENERATION OF FRAGMENTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25176932 ↗
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 reports
- INHANCE 6205-10-105Depuy (Ireland) · DRIVER, PROSTHESIS191 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page