EXPEDIUM 179912645Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 6.35 x 6 x 45mm · 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 10705034086477), received between Oct 22, 2017 and Oct 22, 2017 — 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.
Most reported problems
Device problems
- Break1
- Device Dislodged or Dislocated1
Patient problems
- Failure of Implant1
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 22, 2017Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
TWO SET SCREWS OF TWO EXPEDIUM UNIVERSAL CONNECTORS WERE LOOSENED AND ONE GOT TOTALLY OFF ONE MONTH POSTOPERATIVELY AFTER REVISION SURGERY (DUE TO EARLIER BROKEN RODS). AND ONE POLYAXIAL SCREW HEAD OF ONE EXPEDIUM 6.35 POLYAXIAL SCREW GOT OFF WHEN REMOVING THE SCREW WITH THE CORRESPONDING SCREW DRIVER. RODS WILL ALSO BE SENT TO INVESTIGATION. WHAT MIGHT HAVE CAUSED THE LOOSENING OF THE SET SCREWS? THESE PRODUCTS ARE ALSO A PART OF THIS COMPLAINT: EXP SET SCREW 6.35, CATALOG 179902000, LOT ARBC68,1 EA, WILL BE RETURNED EXP 6.35 SCREW POLY 6.0X45, CATALOG 179902000, LOT 133674, 2 EA, WILL BE RETURNED.
Patient problems: Failure of Implant; Injury
MAUDE report 6967819 ↗
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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