EXPEDIUM 279730145Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM DUAL ACTION ROD CLAMP 5.5 · Class 1
Quick summary
This Medos EXPEDIUM dual action rod clamp is a surgical instrument used to hold and tighten rods during spine surgery. The 44 reports mostly describe parts twisting or bending, breaking during surgery, and clamps wearing out or not fitting properly with other equipment. No deaths and no injuries were reported, and reports describe no patient harm. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10705034200170), received between Feb 8, 2021 and Apr 22, 2026 — classified as 44 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (21 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent21
- Break14
- Device-Device Incompatibility8
- Contamination /Decontamination Problem4
- Corroded4
- Device Slipped2
- Mechanical Jam2
Patient problems
- No Clinical Signs, Symptoms or Conditions44
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2026Break
IT WAS REPORTED SEVERAL INSTRUMENTS, INCLUDING TWO EXPEDIUM ROD HOLDERS, BROKE DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955056 ↗MalfunctionApr 22, 2026Break
IT WAS REPORTED SEVERAL INSTRUMENTS, INCLUDING TWO EXPEDIUM ROD HOLDERS, BROKE DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24954953 ↗MalfunctionApr 20, 2026Material Twisted/Bent
IT WAS REPORTED THAT ROD HOLDER WAS WORN. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24931782 ↗MalfunctionApr 20, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE ROD HOLDER WAS WORN. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24928045 ↗MalfunctionApr 20, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE ROD HOLDER WAS WORN. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24928042 ↗MalfunctionApr 20, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE ROD HOLDER WAS WORN. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24928037 ↗MalfunctionApr 20, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE ROD HOLDER WAS WORN. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24928035 ↗MalfunctionApr 20, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE ROD HOLDER WAS WORN. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24928033 ↗MalfunctionApr 20, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE ROD HOLDER WAS WORN. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24928012 ↗MalfunctionApr 20, 2026Material Twisted/Bent
IT WAS REPORTED THAT POLY SHAFT DRIVERS ARE STRIPPED. THE HANDLES ARE NOT RATCHING. THE TAPS ARE DULL AND THE BENDERS ARE DAMAGED, METAL BENT. ROD HOLDERS WORN. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24925345 ↗MalfunctionApr 2, 2026Mechanical Jam
IT WAS REPORTED THAT THE ROD CLAMP EXPERIENCED A FUNCTIONAL FAILURE DURING INTRA-OPERATIVE USE. THE DEVICE'S BUTTON BECAME JAMMED, PREVENTING RELEASE OF THE GRIP ON THE ROD AND MAKING IT DIFFICULT TO REMOVE THE ROD. THERE WAS NO DELAY IN THE PROCEDURE, NO PATIENT INVOLVEMENT, AND THE CASE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATIVE DEVICE. THE EVENT WAS REPORTED AS A PRE-EMPTIVE MEASURE TO RAISE AWARENESS OF POTENTIAL ISSUES WITH THE NEW INSERTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767438 ↗MalfunctionApr 2, 2026Mechanical Jam
IT WAS REPORTED THAT THE ROD CLAMP EXPERIENCED A FUNCTIONAL FAILURE DURING INTRA-OPERATIVE USE. THE DEVICE'S BUTTON BECAME JAMMED, PREVENTING RELEASE OF THE GRIP ON THE ROD AND MAKING IT DIFFICULT TO REMOVE THE ROD. THERE WAS NO DELAY IN THE PROCEDURE, NO PATIENT INVOLVEMENT, AND THE CASE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATIVE DEVICE. THE EVENT WAS REPORTED AS A PRE-EMPTIVE MEASURE TO RAISE AWARENESS OF POTENTIAL ISSUES WITH THE NEW INSERTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767434 ↗MalfunctionJan 20, 2026Break
IT WAS REPORTED ON AN UNKNOWN DATE THAT LOCKING CLAMP BROKE. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. IT IS ALSO NOT KNOWN IF THERE WAS ANY SURGICAL DELAY DUE TO THE REPORTED EVENT AND IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24112987 ↗MalfunctionJan 20, 2026Break
IT WAS REPORTED ON AN UNKNOWN DATE THAT LOCKING CLAMP BROKE. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. IT IS ALSO NOT KNOWN IF THERE WAS ANY SURGICAL DELAY DUE TO THE REPORTED EVENT AND IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24112986 ↗MalfunctionJan 20, 2026Break
IT WAS REPORTED ON AN UNKNOWN DATE THAT LOCKING CLAMP BROKE. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. IT IS ALSO NOT KNOWN IF THERE WAS ANY SURGICAL DELAY DUE TO THE REPORTED EVENT AND IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24112983 ↗MalfunctionJan 20, 2026Break
IT WAS REPORTED ON AN UNKNOWN DATE THAT LOCKING CLAMP BROKE. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. IT IS ALSO NOT KNOWN IF THERE WAS ANY SURGICAL DELAY DUE TO THE REPORTED EVENT AND IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT STATUS/OUTCOME/CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24112982 ↗MalfunctionJan 6, 2026Device Slipped; Device-Device Incompatibility
IT WAS REPORTED THAT THE RATCHETING MECHANISM ON ROD HOLDER SOMETIMES DOESN'T HOLD WHEN TIGHTENED AND THE HOLDER SUDDENLY POPS OPEN. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23975127 ↗MalfunctionNov 11, 2025Break; Break
WHEN REMOVING THE ROD, THE RATCHET MECHANISM AT THE TOP OF THE ROD HOLDER SNAPPED AND THE HOLDING MECHANISM FELL APART. THERE WAS MINIMAL DELAY TO SURGERY. THERE ARE NO KNOWN ADVERSE CONSEQUENCES FOR THE PATIENT. PRODUCTS HAVE BEEN DISPOSED OF BY THE HOSPITAL DUE TO MULTIPLE SHARP POINTS AND CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23525789 ↗MalfunctionNov 10, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. WHEN REMOVING THE ROD, THE RATCHET MECHANISM AT THE TOP OF THE ROD HOLDER SNAPPED AND THE HOLDING MECHANISM FELL APART. THERE ARE NO KNOWN ADVERSE CONSEQUENCES FOR THE PATIENT, MINIMAL DELAY TO SURGERY. PRODUCTS HAVE BEEN DISPOSED OF BY THE HOSPITAL DUE TO MULTIPLE SHARP POINTS AND CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23511142 ↗MalfunctionAug 11, 2025Device Slipped; Device-Device Incompatibility; Material Twisted/Bent; Device Slipped; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE SURGEON FOUND THAT THIS EXPEDIUM ROD HOLDER WAS NO LONGER GRIPPING THE ROD AND WAS SLIDING DUE TO SOME WEAR AND TEAR WHEN IT HOLDS THE ROD. THE CASE WAS COMPLETED WITHOUT IMPACT TO THE PATIENT, NO DELAYS AND ANOTHER TYPE OF ROD HOLDER WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22773148 ↗MalfunctionMar 3, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN-SITU BENDER WAS SNAPPED AND ROD HOLDER BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21503959 ↗MalfunctionMar 3, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN-SITU BENDER WAS SNAPPED AND ROD HOLDER BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21503737 ↗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 21326805 ↗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 21326801 ↗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 21326798 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.