Skip to content

EXPEDIUM 279718101Recalls & reported problems

Medos International Sàrl · EXPEDIUM SPINE SYSTEM CLOSED POLYAXIAL SCREWDRIVER T27 · Class 1

All models of EXPEDIUM (291)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034301396), received between Sep 13, 2018 and Feb 10, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18, 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: 1 reportsMar 2025: 0 reportsApr 2025: 0 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: 0 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

  • Break5
  • Corroded1

Patient problems

  • No Consequences Or Impact To Patient4
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 10, 2025Break; Corroded; Break; Corroded

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REPORTED INSTRUMENTS WERE RUSTY, HAD BROKEN THREADS AND BROKEN TIPS. THERE WAS NO PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21343456 ↗
  • MalfunctionOct 17, 2019Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2019, THE T27 CLOSED HEAD EXPEDIUM 6.35 SCREW DRIVER BROKEN DURING SURGERY. SURGICAL DELAY AND PROCEDURE OUTCOME ARE UNKNOWN. THERE WAS NO PATIENT HARM/CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9204657 ↗
  • MalfunctionSep 13, 2018Break; Break

    IT WAS REPORTED THAT THE PROCEDURE WAS A REVISION SURGERY WITH PREVIOUS EXPEDIUM 6.35 S2 ALAR ILIAC SCREWS IN PLACE. WE TOOK OUT A 9X100 SCREW AND THE DOCTOR DECIDED TO UPSIZE TO A 10X100 CLOSED HEAD EXP 6.35 SCREW. THE DOCTOR PLACED THE SCREW INITIALLY WITHOUT PROBLEM, BUT LATER DECIDED HE WANTED TO ADVANCE THE SCREW A COUPLE MORE ROTATIONS. DURING THIS STEP, WE BROKE 3 DIFFERENT EXP 6.35 SCREWDRIVERS, 2 OF THE T27 SNAPPED OFF AND THE OTHER DRIVER HAD THE CONNECTION THREADS SNAP OFF. THE SURGEON DECIDED TO LEAVE THE SCREW AS IS AFTER THE 3RD DRIVER BROKE. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7873441 ↗
  • MalfunctionSep 13, 2018Break; Break

    IT WAS REPORTED THAT THE PROCEDURE WAS A REVISION SURGERY WITH PREVIOUS EXPEDIUM 6.35 S2 ALAR ILIAC SCREWS IN PLACE. WE TOOK OUT A 9X100 SCREW AND THE DOCTOR DECIDED TO UPSIZE TO A 10X100 CLOSED HEAD EXP 6.35 SCREW. THE DOCTOR PLACED THE SCREW INITIALLY WITHOUT PROBLEM, BUT LATER DECIDED HE WANTED TO ADVANCE THE SCREW A COUPLE MORE ROTATIONS. DURING THIS STEP, WE BROKE 3 DIFFERENT EXP 6.35 SCREWDRIVERS, 2 OF THE T27 SNAPPED OFF AND THE OTHER DRIVER HAD THE CONNECTION THREADS SNAP OFF. THE SURGEON DECIDED TO LEAVE THE SCREW AS IS AFTER THE 3RD DRIVER BROKE. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7873421 ↗
  • MalfunctionSep 13, 2018Break; Break

    IT WAS REPORTED THAT THE PROCEDURE WAS A REVISION SURGERY WITH PREVIOUS EXPEDIUM 6.35 S2 ALAR ILIAC SCREWS IN PLACE. WE TOOK OUT A 9X100 SCREW AND THE DOCTOR DECIDED TO UPSIZE TO A 10X100 CLOSED HEAD EXP 6.35 SCREW. THE DOCTOR PLACED THE SCREW INITIALLY WITHOUT PROBLEM, BUT LATER DECIDED HE WANTED TO ADVANCE THE SCREW A COUPLE MORE ROTATIONS. DURING THIS STEP, WE BROKE 3 DIFFERENT EXP 6.35 SCREWDRIVERS, 2 OF THE T27 SNAPPED OFF AND THE OTHER DRIVER HAD THE CONNECTION THREADS SNAP OFF. THE SURGEON DECIDED TO LEAVE THE SCREW AS IS AFTER THE 3RD DRIVER BROKE. PATIENT CONSEQUENCE?: NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7873046 ↗

Other DRIVER, PROSTHESIS devices

All DRIVER, PROSTHESIS devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page