EXPEDIUM 279703150Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM ERGONOMIC RATCHETING T-HANDLE 5.5/6.35mm · Class 1
All models of EXPEDIUM (291)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034198750), received between Aug 10, 2020 and Feb 6, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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
- Contamination /Decontamination Problem2
- Corroded2
- Break1
- Device-Device Incompatibility1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2025Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, SEVERAL INSTRUMENTS WERE INSPECTED AND DENIED STERILIZATION DUE TO RUST FORMING ON THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21326920 ↗MalfunctionFeb 6, 2025Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, SEVERAL INSTRUMENTS WERE INSPECTED AND DENIED STERILIZATION DUE TO RUST FORMING ON THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21326795 ↗MalfunctionMar 11, 2022Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
IT WAS REPORTED THAT ON (B)(6) 2022 DURING AN UNKNOWN PROCEDURE THE RATCHETING T-HANDLE DRIVE MECHANISM HAD BEEN DAMAGED WHEN LOADING ROD PUSHER. HANDLE CAN NO LONGER LOCK ANY OTHER INSTRUMENTS IN. PROCEDURE COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) ERGONOMIC RATCHETING T-HANDLE THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13736557 ↗MalfunctionAug 10, 2020Break; Break
IT WAS FURTHER REPORTED THAT THERE IS NO PATIENT INVOLVEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10385570 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- 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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