EXPEDIUM 179722645Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM DI POLYAXIAL SCREW 5.5 x 6.0 x 45mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034070636), received between Aug 18, 2017 and Apr 4, 2018 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (3 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.
Most reported problems
Device problems
- Break3
Patient problems
- Device Embedded In Tissue or Plaque2
- Not Applicable1
- Spinal Column Injury1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 4, 2018Break; Break
DURING TODAY¿S REVISION SURGERY IN (B)(6) MEDICAL CENTER (B)(6), SURGEON DISCOVERED THAT ONE OF THE SCREWS IN THE PATIENT IS BROKEN. SCREW WAS IMPLANTED DURING PRIMARY SURGERY (PROBABLY IN (B)(6) HOSPITAL IN 2014) AND BREAKAGE IS NOT A CONSEQUENCE OF TODAY¿S SURGERY NOR WAS THE REASON FOR REVISION SURGERY IN THE FIRST PLACE (REASON FOR TODAY¿S REVISION SURGERY WAS PROLONGING OF THE CONSTRUCT ¿ PRIMARY CONSTRUCT L3-S1, NEW CONSTRUCT L2-S1, S1 SCREW WAS BROKEN). BROKEN HEAD WAS REMOVED, SHAFT OF THE SCREW WAS LEFT IN THE PATIENT. OPERATOR WAS NEUROSURGEON DR. (B)(6) FROM (B)(6), PRODUCT INVOLVED WAS EXPEDIUM DUAL INNIE SCREW 6X45MM (CODE 179722645, LOT: APNDMR). USER HAS EXPERIENCE WITH THIS SYSTEM, (B)(6) (MARKET DEVELOPMENT MANAGER) AND (B)(6) (SALES REP) WERE PRESENT DURING THE PROCEDURE. BROKEN HEAD WILL BE RETURNED TO US NEXT WEEK WHEN IT IS STERILIZED.
Patient problems: Not Applicable; Spinal Column Injury
MAUDE report 7395843 ↗MalfunctionAug 18, 2017Break; Break
INTRAOPERATIVELY BREAKAGE OF SCREW HEAD WHILE INSERT THE ROD.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6804739 ↗MalfunctionAug 18, 2017Break; Break
INTRAOPERATIVELY BREAKAGE OF SCREW HEAD WHILE INSERT THE ROD.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6804672 ↗
Other Orthosis, spondylolisthesis spinal fixation devices
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- 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 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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