EXPEDIUM 279726401Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM ALIGNMENT DEVICE · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Expedium spine alignment device is a surgical instrument used to line up spinal implants during surgery. All 129 reports are malfunctions, with no deaths or injuries; most flag cleaning problems, such as staff being unable to remove cement from its hollow tubes. Reports rose to 32 in the last 12 months from 1 in the 12 months before. No recalls name 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
- 125
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 10705034199498), received between Mar 1, 2018 and Aug 13, 2026 — classified as 125 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (113 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
- Contamination /Decontamination Problem113
- Device-Device Incompatibility7
- Break5
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions111
- No Consequences Or Impact To Patient15
- No Patient Involvement2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 125 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233117 ↗MalfunctionAug 13, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233114 ↗MalfunctionAug 13, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233111 ↗MalfunctionAug 13, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233109 ↗MalfunctionMay 14, 2026Contamination /Decontamination Problem
IT WAS REPORTED THE HOSPITAL STAFF WAS UNABLE TO CLEAN THE LUMEN OF THE CEMENT OFF OF THE FENESTRATED CANNULAS. THERE WAS NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25174441 ↗MalfunctionMay 14, 2026Contamination /Decontamination Problem
IT WAS REPORTED THE HOSPITAL STAFF WAS UNABLE TO CLEAN THE LUMEN OF THE CEMENT OFF OF THE FENESTRATED CANNULAS. THERE WAS NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25174431 ↗MalfunctionMay 14, 2026Contamination /Decontamination Problem
IT WAS REPORTED THE HOSPITAL STAFF WAS UNABLE TO CLEAN THE LUMEN OF THE CEMENT OFF OF THE FENESTRATED CANNULAS. THERE WAS NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25174423 ↗MalfunctionMay 14, 2026Contamination /Decontamination Problem
IT WAS REPORTED THE HOSPITAL STAFF WAS UNABLE TO CLEAN THE LUMEN OF THE CEMENT OFF OF THE FENESTRATED CANNULAS. THERE WAS NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25174415 ↗MalfunctionMay 14, 2026Contamination /Decontamination Problem
IT WAS REPORTED THE HOSPITAL STAFF WAS UNABLE TO CLEAN THE LUMEN OF THE CEMENT OFF OF THE FENESTRATED CANNULAS. THERE WAS NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25174407 ↗MalfunctionMay 14, 2026Contamination /Decontamination Problem
IT WAS REPORTED THE HOSPITAL STAFF WAS UNABLE TO CLEAN THE LUMEN OF THE CEMENT OFF OF THE FENESTRATED CANNULAS. THERE WAS NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25174399 ↗MalfunctionMay 14, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT FOLLOWING A SPINAL FUSION, HOSPITAL MDR STAFF DEEMED FENESTRATED CANNULAS TO BE UNUSABLE, DUE TO INABILITY TO CLEAN THE LUMEN OF CEMENT. THE SALES REPRESENTATIVE HAD ATTEMPTED CLEANING IMMEDIATELY AFTER USE. HOWEVER, IT SEEMED SOME REMAINED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25172637 ↗MalfunctionMay 14, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT FOLLOWING A SPINAL FUSION, HOSPITAL MDR STAFF DEEMED FENESTRATED CANNULAS TO BE UNUSABLE, DUE TO INABILITY TO CLEAN THE LUMEN OF CEMENT. THE SALES REPRESENTATIVE HAD ATTEMPTED CLEANING IMMEDIATELY AFTER USE HOWEVER, IT SEEMED SOME REMAINED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25172635 ↗MalfunctionMay 14, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT FOLLOWING A SPINAL FUSION, HOSPITAL MDR STAFF DEEMED FENESTRATED CANNULAS TO BE UNUSABLE, DUE TO INABILITY TO CLEAN THE LUMEN OF CEMENT. THE SALES REPRESENTATIVE HAD ATTEMPTED CLEANING IMMEDIATELY AFTER USE HOWEVER, IT SEEMED SOME REMAINED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25172633 ↗MalfunctionMay 14, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT FOLLOWING A SPINAL FUSION, HOSPITAL MDR STAFF DEEMED FENESTRATED CANNULAS TO BE UNUSABLE, DUE TO INABILITY TO CLEAN THE LUMEN OF CEMENT. THE SALES REPRESENTATIVE HAD ATTEMPTED CLEANING IMMEDIATELY AFTER USE HOWEVER, IT SEEMED SOME REMAINED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25172631 ↗MalfunctionMay 14, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT FOLLOWING A SPINAL FUSION, HOSPITAL MDR STAFF DEEMED FENESTRATED CANNULAS TO BE UNUSABLE, DUE TO INABILITY TO CLEAN THE LUMEN OF CEMENT. THE SALES REPRESENTATIVE HAD ATTEMPTED CLEANING IMMEDIATELY AFTER USE HOWEVER, IT SEEMED SOME REMAINED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25172629 ↗MalfunctionMay 14, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT FOLLOWING A SPINAL FUSION, HOSPITAL MDR STAFF DEEMED FENESTRATED CANNULAS TO BE UNUSABLE, DUE TO INABILITY TO CLEAN THE LUMEN OF CEMENT. THE SALES REPRESENTATIVE HAD ATTEMPTED CLEANING IMMEDIATELY AFTER USE HOWEVER, IT SEEMED SOME REMAINED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25172628 ↗MalfunctionMay 14, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT FOLLOWING A SPINAL FUSION, HOSPITAL MDR STAFF DEEMED FENESTRATED CANNULAS TO BE UNUSABLE, DUE TO INABILITY TO CLEAN THE LUMEN OF CEMENT. THE SALES REPRESENTATIVE HAD ATTEMPTED CLEANING IMMEDIATELY AFTER USE HOWEVER, IT SEEMED SOME REMAINED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25172627 ↗MalfunctionMay 14, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT FOLLOWING A SPINAL FUSION, HOSPITAL MDR STAFF DEEMED FENESTRATED CANNULAS TO BE UNUSABLE, DUE TO INABILITY TO CLEAN THE LUMEN OF CEMENT. THE SALES REPRESENTATIVE HAD ATTEMPTED CLEANING IMMEDIATELY AFTER USE HOWEVER, IT SEEMED SOME REMAINED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25172626 ↗MalfunctionMay 14, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT FOLLOWING A SPINAL FUSION, HOSPITAL MDR STAFF DEEMED FENESTRATED CANNULAS TO BE UNUSABLE, DUE TO INABILITY TO CLEAN THE LUMEN OF CEMENT. THE SALES REPRESENTATIVE HAD ATTEMPTED CLEANING IMMEDIATELY AFTER USE HOWEVER, IT SEEMED SOME REMAINED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25172618 ↗MalfunctionMay 14, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT FOLLOWING A SPINAL FUSION, HOSPITAL MDR STAFF DEEMED FENESTRATED CANNULAS TO BE UNUSABLE, DUE TO INABILITY TO CLEAN THE LUMEN OF CEMENT. THE SALES REPRESENTATIVE HAD ATTEMPTED CLEANING IMMEDIATELY AFTER USE HOWEVER, IT SEEMED SOME REMAINED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25172617 ↗MalfunctionApr 30, 2026Contamination /Decontamination Problem
OPEN ALIGN DEVICES (ITEM #2797-26-401) ALL INDICATING THE PRESENCE OF CEMENT IN THE CANNULA WHICH CANNOT BE REMOVED BY STAFF. NO PATIENT INVOLVEMENT, WAS IDENTIFIED AFTER CASE WAS COMPLETED DURING REPROCESSING OF INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25039530 ↗MalfunctionApr 30, 2026Contamination /Decontamination Problem
OPEN ALIGN DEVICES (ITEM #2797-26-401) ALL INDICATING THE PRESENCE OF CEMENT IN THE CANNULA WHICH CANNOT BE REMOVED BY STAFF. NO PATIENT INVOLVEMENT, WAS IDENTIFIED AFTER CASE WAS COMPLETED DURING REPROCESSING OF INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25039528 ↗MalfunctionApr 30, 2026Contamination /Decontamination Problem
OPEN ALIGN DEVICES (ITEM #2797-26-401) ALL INDICATING THE PRESENCE OF CEMENT IN THE CANNULA WHICH CANNOT BE REMOVED BY STAFF. NO PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25039473 ↗MalfunctionApr 30, 2026Contamination /Decontamination Problem
OPEN ALIGN DEVICES (ITEM #2797-26-401) ALL INDICATING THE PRESENCE OF CEMENT IN THE CANNULA WHICH CANNOT BE REMOVED BY STAFF. NO PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25039470 ↗MalfunctionApr 30, 2026Contamination /Decontamination Problem
OPEN ALIGN DEVICES (ITEM #2797-26-401) ALL INDICATING THE PRESENCE OF CEMENT IN THE CANNULA WHICH CANNOT BE REMOVED BY STAFF. NO PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25039463 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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