EXPEDIUM VERSE 299704255Recalls & reported problems
Medos International Sàrl · EXPEDIUM VERSE SPINE SYSTEM COUNTER TORQUE HANDLE · Class 1
All models of EXPEDIUM VERSE (90)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034467474), received between Jul 2, 2020 and Oct 27, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility3
- Mechanical Jam3
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT DURING SURGERY, TWO INSTRUMENTS ON THE CONSIGNED EXPEDIUM VERSE SET HAD ISSUES. THE BUTTON ON THE SIDE OF THE WRENCH/COUNTER TORQUE WAS JAMMED AND COULD NOT CONNECT TO THE FACILITATOR TO FINAL TIGHTEN THE SCREW. NO HARM WAS DONE TO THE PATIENT. THIS ADDED 5 MINUTES TO SURGERY TIME. THE X25 FINAL TIGHTENER HAD STRIPPED, THEREFORE PREVENTING THE SET SCREWS FROM BEING FINAL TIGHTENED. THIS LED TO 3 SCREWS CROSS THREADING AND ADDED 5 MINUTES TO THE PROCEDURE. NO OTHER HARM WAS DONE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23390956 ↗MalfunctionNov 8, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT ON (B)(6) 2024, THE SCRUB NURSE WAS ASSEMBLING INSTRUMENTATION AT THE BEGINNING OF OR SETUP AND NOTED THAT THE VERSE COUNTER TORQUE HANDLE ITEM NUMBER 299704255 BUTTON WHICH GETS PUSHED WAS JAMMED. ALSO NOTED WAS ITEM 299704230 X25 INSERTER / TIGHTENER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20640725 ↗MalfunctionJan 26, 2023Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16247216 ↗MalfunctionApr 8, 2022Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PSF(TH2-SAI) FOR TREATING ADULT SPINAL DEFORMITY ON (B)(6) 2022. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THEY WERE NOT ABLE DETACH THE FACILITATOR FROM THE HANDLE DURING POSTOPERATIVE CLEANSING. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VERSE COUNTER TORQUE HANDLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14054180 ↗MalfunctionNov 2, 2020Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A POSTERIOR THORACOLUMBAR FUSION AT TH10-L2 TREATING TRAUMATIC INJURY ON (B)(6) 2020, THE NURSE TRIED TO ATTACH A FACILITATOR TO THE TORQUE HANDLE. WHEN SHE PRESSED THE BUTTON OF THE HANDLE, HER GLOVE STUCK IN THE BUTTON. SHE CONNECTED THE FACILITATOR IN OTHER WAYS, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN FACILITATOR (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) VERSE COUNTER TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10770502 ↗MalfunctionJul 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, AS THE SCRUB NURSE TOOK THE INSTRUMENT OUT OF THE TRAY, PART OF THE BUTTON CAME LOOSE AND FELL OUT. THE BUTTON PORTION WAS KEPT TO THE SIDE AND THE OTHER END OF THE COUNTER TORQUE WAS USED DURING FINAL TIGHTENING. NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM COUNTER TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10225207 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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