EXPEDIUM 179777600Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM COMM. PURE TI ROD W/ HEX END 5.5 x 600mm · Class 2 · Implant
All models of EXPEDIUM (291)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034078489), received between Jan 30, 2024 and Jan 30, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Material Twisted/Bent1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 30, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON JANUARY 15, 2024, THAT THIS PATIENT HAD A SCOLIOSIS CORRECTION APPROXIMATELY 10 YEARS AGO. THE PATIENT WAS ASYMPTOMATIC, HOWEVER DURING A MEDICAL EXAM IT WAS FOUND THAT ONE OF THE SCREWS (LEFT L3) .6X45 FAS SCREW HAS BROKEN, LEAVING THE HEAD UNATTACHED FROM THE SHAFT. THE CONTRALATERAL ROD WAS ALSO BROKEN, MEANING THAT A CROSS CONNECTOR HAD TO BE ADDED TO THE CONSTRUCT TO ATTACH A SMALLER ROD TO THE LOWER CONSTRUCT. TWO SCREWS HAD TO BE REVISED DURING THE PROCEDURE. BOTH THE PATIENT AND SURGEON HAVE REQUESTED THAT THIS IS INVESTIGATED AND WOULD LIKE TO BE INFORMED OF THE OUTCOME. THE PATIENT WAS REVISED 10 YEARS AFTER HER INITIAL SURGERY. FRAGMENTS WERE NOT GENERATED. PATIENT STATUS: FIT AND WELL. THIS REPORT IS FOR ONE (1)EXP TI CP ROD, 600 MM THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 18610217 ↗
Other Orthosis, spondylolisthesis spinal fixation devices
- CD HORIZON® Spinal System 7540020Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation257 reports
- MANTIS Redux 48289999Stryker Corporation · Orthosis, spondylolisthesis spinal fixation76 reports
- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 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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