EXPEDIUM 179912750Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 6.35 x 7 x 50mm · Class 2 · Implant
All models of EXPEDIUM (291)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034086651), received between Sep 11, 2018 and Jun 12, 2025 — classified as 2 injuries.
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
- Not Applicable1
- Pain1
Recent adverse event reports
The 2 most recent of 2 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 22196426 ↗InjurySep 11, 2018Break; Break
IT WAS REPORTED THAT THE PATIENT WENT TO CLINIC FOR ROUTINE POST OPERATIVE FOLLOW UP AND COMPLAINED OF "HIP PAIN". AN X-RAY WAS PERFORMED AND LEFT S-1 SCREW WAS FOUND TO BE FRACTURED. THE CLINIC NOTES STATES THAT THE FRACTURED SCREW IS NOT LIKELY THE CAUSE OF THE PATIENT'S PAIN. (PATIENT HAD REVISION SURGERY ON (B)(6) 2018 FOR A PREVIOUS FUSION SURGERY RESULTING IN NON-UNION (NON-DEPUY HARDWARE). THE PATIENT WAS EXPOSED TO 4 HOURS OF ANESTHESIA. CONSTRUCT WAS PERFORMED WITH EXPEDIUM 6.35 POLYAXIAL SCREWS AND RODS AT L3-S1. MALFUNCTION: DEVICE BREAKAGE.
Patient problems: Not Applicable; Pain
MAUDE report 7865867 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 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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