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EXPEDIUM 279703140Recalls & reported problems

Medos International Sàrl · EXPEDIUM SPINE SYSTEM ELLIPTICAL HANDLE - RATCHETING ADAPTER · Class 1

All models of EXPEDIUM (291)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
17
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705034198743), received between Jul 20, 2023 and Jun 9, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (15 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: 1 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 10 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 2 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202610
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break15
  • Mechanical Jam11
  • Device-Device Incompatibility2

Patient problems

  • No Clinical Signs, Symptoms or Conditions17

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 9, 2026Break

    IT WAS REPORTED THAT RATCHETING PORTION OF DRIVER WAS BROKEN. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25444877 ↗
  • MalfunctionJun 9, 2026Break

    IT WAS REPORTED THAT RATCHETING PORTION OF DRIVER WAS BROKEN. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25444876 ↗
  • MalfunctionAug 4, 2025Break; Break

    IT WAS REPORTED THAT DURING A PROCEDURE; THE RATCHETING HANDLE WAS BROKEN' WON¿T RATCHET. THERE WAS NO SURGERY DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22708068 ↗
  • MalfunctionDec 13, 2024Break; Break

    IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENT BROKE DURING SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO GENERATION OF FRAGMENTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20926071 ↗
  • MalfunctionSep 17, 2024Break; Mechanical Jam; Break; Mechanical Jam

    IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING INSPECTION IT WAS NOTICED THAT THE RATCHING MECHANISM WAS BROKEN, COULD NOT TURN TO REVERSE. THERE WERE NO BROKEN FRAGMENTS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20237939 ↗
  • MalfunctionSep 17, 2024Break; Mechanical Jam; Break; Mechanical Jam

    IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING INSPECTION IT WAS NOTICED THAT THE RATCHING MECHANISM WAS BROKEN, COULD NOT TURN TO REVERSE. THERE WERE NO BROKEN FRAGMENTS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20237914 ↗
  • MalfunctionSep 17, 2024Break; Mechanical Jam; Break; Mechanical Jam

    IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING INSPECTION IT WAS NOTICED THAT THE RATCHING MECHANISM WAS BROKEN, COULD NOT TURN TO REVERSE. THERE WERE NO BROKEN FRAGMENTS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20237901 ↗
  • MalfunctionSep 17, 2024Break; Mechanical Jam; Break; Mechanical Jam

    IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING INSPECTION IT WAS NOTICED THAT THE RATCHING MECHANISM WAS BROKEN, COULD NOT TURN TO REVERSE. THERE WERE NO BROKEN FRAGMENTS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20237900 ↗
  • MalfunctionSep 17, 2024Break; Mechanical Jam; Break; Mechanical Jam

    IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING INSPECTION IT WAS NOTICED THAT THE RATCHING MECHANISM WAS BROKEN, COULD NOT TURN TO REVERSE. THERE WERE NO BROKEN FRAGMENTS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20237895 ↗
  • MalfunctionSep 17, 2024Break; Mechanical Jam; Break; Mechanical Jam

    IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING INSPECTION IT WAS NOTICED THAT THE RATCHING MECHANISM WAS BROKEN, COULD NOT TURN TO REVERSE. THERE WERE NO BROKEN FRAGMENTS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20237893 ↗
  • MalfunctionSep 17, 2024Break; Mechanical Jam; Break; Mechanical Jam

    IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING INSPECTION IT WAS NOTICED THAT THE RATCHING MECHANISM WAS BROKEN, COULD NOT TURN TO REVERSE. THERE WERE NO BROKEN FRAGMENTS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20237879 ↗
  • MalfunctionSep 17, 2024Break; Mechanical Jam; Break; Mechanical Jam

    IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING INSPECTION IT WAS NOTICED THAT THE RATCHING MECHANISM WAS BROKEN, COULD NOT TURN TO REVERSE. THERE WERE NO BROKEN FRAGMENTS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20237791 ↗
  • MalfunctionSep 17, 2024Break; Mechanical Jam; Break; Mechanical Jam

    IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING INSPECTION IT WAS NOTICED THAT THE RATCHING MECHANISM WAS BROKEN, COULD NOT TURN TO REVERSE. THERE WERE NO BROKEN FRAGMENTS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20237759 ↗
  • MalfunctionSep 17, 2024Break; Mechanical Jam; Break; Mechanical Jam

    IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING INSPECTION IT WAS NOTICED THAT THE RATCHING MECHANISM WAS BROKEN, COULD NOT TURN TO REVERSE. THERE WERE NO BROKEN FRAGMENTS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20237627 ↗
  • MalfunctionApr 4, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

    IT WAS REPORTED THAT ON (B)(6) 2024 THE HANDLE WAS PULLED FROM STOCK TO USE AS A "MAKE FROM" PART FOR A SPECIAL REQUEST TEAM DEVICE AND THE BUTTON WAS STICKING AND UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM ELLIPTICAL HANDLE RATCHETING ADAPTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19039949 ↗
  • MalfunctionFeb 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ONE OF THE 1085 BASE SIEVES IS A DEFECTIVE HANDLE 279703140. THE HANDLE PART TURNS OFF FROM THE RATCHET PART WHEN YOU SCREW IT AROUND TO THE LEFT. NO PATIENT HARM. IT WAS NOTICED INTRAOPERATIVELY. THIS REPORT IS FOR ONE (1) ELLIPTICAL RATCHETING HANDLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18691312 ↗
  • MalfunctionJul 20, 2023Break; Break

    IT WAS REPORTED THAT DURING A POSTERIOR SPINAL FUSION PROCEDURE ON (B)(6) 2023, THE RATCHETING HANDLE WAS BROKEN. IT WAS INSUFFICIENT TO PLACE SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY, AND NO FRAGMENTS WERE RETAINED IN THE PATIENT. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM ELLIPTICAL HANDLE - RATCHETING ADAPTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17360299 ↗

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