EXPEDIUM 279702150Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM ERGONOMIC T-HANDLE · Class 1
All models of EXPEDIUM (291)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034198538), received between Mar 30, 2022 and Apr 29, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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 Incompatibility8
- Appropriate Device Problem Term/Code Not Available1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE QUICK-CONNECT SCREWDRIVER AND ERGONOMIC T-HANDLE WERE STUCK TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25032798 ↗MalfunctionApr 1, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. WHEN PLACING IN ONE OF THE TRANSPEDICULAR SCREWS, IT LOST ITS THREAD PASSAGE WHICH COMES OUT AS A WIRE OR RECESS OF THE SAME CLOSING SCREW. IT WAS TRIED SEVERAL TIMES AND THREE UNITS OF THE CLOSING SCREWS WERE AFFECTED. THESE WERE NOT IMPLANTED IN THE PATIENT. IN ADDITION, THE T-HANDLE PIECE GOT STUCK WITH THE PUSHER OR BAR PUSHER. THE SURGERY WAS SUCCESSFULLY COMPLETED, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.
Patient problems: Insufficient Information
MAUDE report 21738725 ↗MalfunctionOct 2, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 DURING LOAN KIT INSPECTION, THE HANDLE IN QUESTION WAS FOUND TO BE UNABLE TO HOLD AND LOCK TAPS AS INTENDED. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM ERGONOMIC T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17853591 ↗MalfunctionFeb 13, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE T HANDLE WAS NOT SPRING LOADING CORRECTLY TO THE DRIVER SHAFT AND NEEDS REPAIR. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT, AND THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS COMPLETED BY USING THE OTHER T HANDLE IN THE SET, ALTHOUGH IT WAS NOT IDEAL TO SWAP THEM DURING THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM ERGONOMIC T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4)..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16366657 ↗MalfunctionJan 31, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THE MECHANISM THAT ATTACHES TO THE SHAVERS USED WITH THE HANDLE IS SLOW, UNRELIABLE AND GETS STUCK ON THE SHAVERS. SURGERY WAS NOT DELAYED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW HANDLE WAS USED. THIS COMPLAINT INVOLVES ONE(1) DEVICE. THIS REPORT IS FOR ONE (1) ERGONOMIC T-HANDLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16273232 ↗MalfunctionOct 4, 2022Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THE DRIVER IN QUESTION WAS FOUND TO BE STRIPPED. NO FURTHER INFORMATION IS AVAILABLE. IT WAS FURTHER REPORTED THAT THE HANDLES ARE PRONE TO DAMAGE BECAUSE THE SLEEVE GETS STUCK. THIS REPORT IS FOR A EXPEDIUM SPINE SYSTEM SCREWDRIVER T20. THIS IS REPORT 5 OF 5 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15540032 ↗MalfunctionSep 2, 2022Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT DEVICE IS DAMAGED. NO FURTHER INFORMATION WAS PROVIDED. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS REVEALED THAT THE CONNECTOR OF THE ERGONOMIC T-HANDLE HAS BROKEN, THE BROKEN FRAGMENTS WAS NOT RETURNED. THIS REPORT IS FOR ONE (1) ERGONOMIC T-HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15351147 ↗MalfunctionJul 13, 2022Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available
DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT AFTER A PROCEDURE ON (B)(6) 2022, THE HEAD ADJUSTER ATTACHED TO THE T-HANDLE WAS EXTREMELY DIFFICULT TO SEPARATE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A EXPEDIUM SPINE SYSTEM ERGONOMIC T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14999237 ↗MalfunctionMar 30, 2022Device-Device Incompatibility; Device-Device Incompatibility
SURGEON USED THE T-HANDLE ATTACHED TO T20 SCREWDRIVER SHAFT TO REMOVE A PEDICLE SCREW AND BURRED THE TIP OF THE SCREWDRIVER AND "WELDED" THE SHAFT TO THE T-HANDLE. UNABLE TO SEPARATE THE TWO (2). NO SURGERY DELAY. A 2ND SCREWDRIVER WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13952106 ↗
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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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