EXPEDIUM 179912745Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 6.35 x 7 x 45mm · Class 2 · Implant
All models of EXPEDIUM (291)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034086644), received between Aug 22, 2019 and Jun 12, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Material Twisted/Bent” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent3
- Loose or Intermittent Connection1
Patient problems
- Insufficient Information3
- No Code Available1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2023 THE PATIENT HAD FUSION SURGERY AT T12-L1 AND A DEPUY EXPEDIUM WAS THE HARDWARE USED IN HER BACK. ON (B)(6) 2024 HER PROVIDERS REALIZED THAT THE HARDWARE HAD FAILED DUE TO "STRIPPED SCREWS" AND REVISION OF THE SURGERY HAD TO BE DONE TO T12-L1 AND TO THE NEXT LEVEL UP WHICH IS THE L1-L2, CAUSING SERIOUS INJURIES TO PATIENT. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22194787 ↗InjuryJun 12, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2023 THE PATIENT HAD FUSION SURGERY AT T12-L1 AND A DEPUY EXPEDIUM WAS THE HARDWARE USED IN HER BACK. ON JANUARY 10, 2024 HER PROVIDERS REALIZED THAT THE HARDWARE HAD FAILED DUE TO "STRIPPED SCREWS" AND REVISION OF THE SURGERY HAD TO BE DONE TO T12-L1 AND TO THE NEXT LEVEL UP WHICH IS THE L1-L2, CAUSING SERIOUS INJURIES TO PATIENT. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22194717 ↗InjuryOct 23, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2023 THE PATIENT HAD FUSION SURGERY AT T12-L1 AND A DEPUY EXPEDIUM WAS THE HARDWARE USED IN HER BACK. ON (B)(6) 2024 THE PATIENT'S PROVIDERS REALIZED THAT THE HARDWARE HAD FAILED DUE TO "STRIPPED SCREWS" AND REVISION OF THE SURGERY HAD TO BE DONE TO T12-L1 AND TO THE NEXT LEVEL UP WHICH IS THE L1-L2, CAUSING SERIOUS INJURIES TO PATIENT.
Patient problems: Insufficient Information
MAUDE report 20513314 ↗InjuryAug 22, 2019Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT ON (B)(6) 2109, THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE LEFT SIDE L4, L5, S1, AND LATERAL CONNECTOR LOCKING CAP POPPED OFF AND WERE REPLACED WITH S1 SCREW WITH LARGER DIAMETER SCREW AND NEW LOCKING CAPS. ON (B)(6) 2017, THE PATIENT HAD T5-PELVIS FUSION. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES.
Patient problems: No Code Available
MAUDE report 8922607 ↗
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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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