EXPEDIUM 179762060Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM ROD 5.5 x 60mm · Class 2 · Implant
All models of EXPEDIUM (291)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034077345), received between Nov 6, 2023 and Feb 12, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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
- Device-Device Incompatibility6
- Defective Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2025Defective Device; Device-Device Incompatibility; Defective Device; Device-Device Incompatibility
IT WAS REPORTED THAT ON JANUARY 30, 2025, THE RODS IN QUESTION WERE FOUND TO BE TOO LARGE TO FIT INSIDE THE DEDICATED IMPLANT CADDY DURING SETTING UP AN INSTRUMENT SET AT HOSPITAL. THERE WAS NO SURGICAL DELAY OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21363809 ↗MalfunctionFeb 12, 2025Defective Device; Device-Device Incompatibility; Defective Device; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2025, THE RODS IN QUESTION WERE FOUND TO BE TOO LARGE TO FIT INSIDE THE DEDICATED IMPLANT CADDY DURING SETTING UP AN INSTRUMENT SET AT HOSPITAL. THERE WAS NO SURGICAL DELAY OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21363806 ↗MalfunctionNov 14, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT BEFORE THE SURGERY ON (B)(6) 2023, IT WAS FOUND THAT THE RODS IN QUESTION WOULD NOT FIT IN THE DEDICATED CADDY. THE LID COULD NOT BE CLOSED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) MOSS MIAMI ROD 5.5X60MM TI. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18136415 ↗MalfunctionNov 14, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT BEFORE THE SURGERY ON (B)(6) 2023, IT WAS FOUND THAT THE RODS IN QUESTION WOULD NOT FIT IN THE DEDICATED CADDY. THE LID COULD NOT BE CLOSED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) MOSS MIAMI ROD 5.5X60MM TI THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18136411 ↗MalfunctionNov 6, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 AN UNKNOWN PROCEDURE WAS BEING PERFORMED FOR AN UNKNOWN DISEASE. BEFORE THE SURGERY, IT WAS FOUND THAT THE PRODUCT IN QUESTION WOULD NOT FIT INTO THE DEDICATED CADDY, THE LID COULD NOT BE CLOSED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM ROD 5.5 X 60MM. THIS IS REPORT 1 OF 2 FOR (B)(4) .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18073956 ↗MalfunctionNov 6, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 AN UNKNOWN PROCEDURE WAS BEING PERFORMED FOR AN UNKNOWN DISEASE. BEFORE THE SURGERY, IT WAS FOUND THAT THE PRODUCT IN QUESTION WOULD NOT FIT INTO THE DEDICATED CADDY, THE LID COULD NOT BE CLOSED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM ROD 5.5 X 60MM. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18073919 ↗
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- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
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- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
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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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