EXPEDIUM VERSE 299704160Recalls & reported problems
Medos International Sàrl · EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL DRIVER, SLEEVE · Class 1
All models of EXPEDIUM VERSE (90)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This EXPEDIUM VERSE spine-system driver sleeve is an orthopedic surgical instrument. The 26 reports mostly describe the instrument becoming worn, twisted, bent, loose, or missing locking parts, with some parts not fitting together; there were no deaths or injuries. No recalls name this device. Reports fell from 10 in the previous 12 months to 3 in the most recent 12 months.
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
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10705034467559), received between Apr 9, 2020 and Dec 3, 2025 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (18 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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent18
- Device-Device Incompatibility6
- Break2
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 3, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PRODUCTS BECAME WORN DUE TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704696 ↗MalfunctionDec 3, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PRODUCTS BECAME WORN DUE TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704671 ↗MalfunctionDec 3, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PRODUCTS BECAME WORN DUE TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704667 ↗MalfunctionOct 20, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE PRODUCT IS WORN FROM USE. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23337112 ↗MalfunctionSep 11, 2025Device-Device Incompatibility; Device-Device Incompatibility
DURING THE PROCEDURE, IT WAS OBSERVED THAT THE PIECE OF INSTRUMENT COMES LOOSE EASILY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23026090 ↗MalfunctionAug 15, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS WERE TWISTED, THE 5/6/7 TAPS WERE BENT, COMPRESSOR AND DISTRACTOR WERE MISSING LOCKING PARTS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22816118 ↗MalfunctionAug 15, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS WERE TWISTED, THE 5/6/7 TAPS WERE BENT, COMPRESSOR AND DISTRACTOR WERE MISSING LOCKING PARTS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22816101 ↗MalfunctionAug 15, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS WERE TWISTED, THE 5/6/7 TAPS WERE BENT, COMPRESSOR AND DISTRACTOR WERE MISSING LOCKING PARTS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22816084 ↗MalfunctionAug 15, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS WERE TWISTED, THE 5/6/7 TAPS WERE BENT, COMPRESSOR AND DISTRACTOR WERE MISSING LOCKING PARTS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22815957 ↗MalfunctionAug 15, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS WERE TWISTED, THE 5/6/7 TAPS WERE BENT, COMPRESSOR AND DISTRACTOR WERE MISSING LOCKING PARTS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22815932 ↗MalfunctionAug 15, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS WERE TWISTED, THE 5/6/7 TAPS WERE BENT, COMPRESSOR AND DISTRACTOR WERE MISSING LOCKING PARTS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22815889 ↗MalfunctionAug 15, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS WERE TWISTED, THE 5/6/7 TAPS WERE BENT, COMPRESSOR AND DISTRACTOR WERE MISSING LOCKING PARTS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22815862 ↗MalfunctionAug 14, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS TWISTED, 5/6/7 TAPS BENT, COMPRESSOR AND DISTRACTOR MISSING LOCKING PARTS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22809952 ↗MalfunctionOct 23, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS ALLEGATION ABOUT STRIPPED DRIVERS. THERE WAS NO PATIENT CONSEQUENCE AND NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20515710 ↗MalfunctionOct 23, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS ALLEGATION ABOUT STRIPPED DRIVERS. THERE WAS NO PATIENT CONSEQUENCE AND NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20515687 ↗MalfunctionOct 22, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS ALLEGATION ABOUT STRIPPED DRIVERS. THERE WAS NO PATIENT CONSEQUENCE AND NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20507878 ↗MalfunctionOct 22, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS ALLEGATION ABOUT STRIPPED DRIVERS. THERE WAS NO PATIENT CONSEQUENCE AND NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20507567 ↗MalfunctionOct 18, 2024Material Twisted/Bent; Material Twisted/Bent
ADDITIONAL INFORMATION RECEIVED STATES THAT THE EVENT OCCURRED DURING POST-OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20482123 ↗MalfunctionOct 18, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DRIVERS ARE STRIPPING. THERE WAS NO PATIENT CONSEQUENCE AND NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20482069 ↗MalfunctionMay 2, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, EVERY TIME THE SCRUB NURSE LOADED A PEDICLE SCREW, THE POLYDRIVER X25 WOULD DISENGAGE FROM TO THE POLYDRIVER HANDLE. THE SAME OCCURRED WHEN THE SURGEON WAS IMPLANTING THE SCREW TO THE PEDICLE AND TRYING TO UNSCREW THE PEDICLE SCREW; THE POLYDRIVER HANDLE DISENGAGED FROM TO THE POLYDRIVER. THE SURGEON HAD A HARD TIME REMOVING THE DRIVER FROM THE PEDICLE SCREW. ANOTHER SET OF DRIVERS WAS USED INSTEAD. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A VERSE POLY DRIVER, HANDLE. THIS IS REPORT 3 OF 4 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16852475 ↗MalfunctionFeb 15, 2023Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
THERE WAS NO PATIENT INVOLVEMENT. THE TIMING OF THE REPORTED EVENT WAS PRE-OPERATIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16380146 ↗MalfunctionNov 12, 2021Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 IN THE MIDDLE OF SPINAL DEFORMITY SURGERY, BOTH SCREWDRIVERS USED TO INSERT SCREWS HAVE BROKEN. THE SURGERY WAS DELAYED FOR TWO (2) HOURS AS HOSPITAL STAFF HAD TO GET ANOTHER SCREWDRIVERS FROM ANOTHER HOSPITAL. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) VERSE POLY DRIVER, SLEEVE. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12804680 ↗MalfunctionNov 12, 2021Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 IN THE MIDDLE OF SPINAL DEFORMITY SURGERY, BOTH SCREWDRIVERS USED TO INSERT SCREWS HAVE BROKEN. THE SURGERY WAS DELAYED FOR TWO (2) HOURS AS HOSPITAL STAFF HAD TO GET ANOTHER SCREWDRIVERS FROM ANOTHER HOSPITAL. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) VERSE POLY DRIVER, SLEEVE. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12804667 ↗MalfunctionJul 6, 2021Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE SCREWDRIVERS DISCONNECTED AFTER PLACING THE SCREWS. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL DRIVER, SLEEVE. THIS IS REPORT 6 OF 6 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12120652 ↗MalfunctionJul 6, 2021Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE SCREWDRIVERS DISCONNECTED AFTER PLACING THE SCREWS. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL DRIVER, SLEEVE. THIS IS REPORT 3 OF 6 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12120549 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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