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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

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