EXPEDIUM 179762382SRecalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM PRE-CONTOURED ROD, LONG diameter 5.5mm · 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 10705034562575), received between Oct 16, 2023 and Oct 16, 2023 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SALES REP WAS CONTACTED BY SURGEON¿S OFFICE STAFF ON 9/27/2023 REQUESTING THE METAL COMPOSITION FOR IMPLANTS USED ON A PATIENT. THE REP EMAILED THE SURGEON AND HIS STAFF DIRECTLY AFTER BEING CONTACTED. HE PROVIDED THEM WITH THE REQUESTED INFORMATION FOR EXPEDIUM AND -METAL COMPOSITION BREAKDOWNS. THEY SAID THE PATIENT WAS EXPERIENCING SWELLING, REDNESS AND IRRITATION IN HIS ABDOMEN. POTENTIALLY MAY BE HAVING A REACTION TO THE IMPLANTS. HE WAS CONTACTED AGAIN BY SURGEON¿S OFFICE THIS AFTERNOON. THE PATIENT WAS REFERRED TO A DERMATOLOGIST AND SURGEON¿S OFFICE ASKED IF WE COULD PROVIDE "PATCH TEST KIT¿. THIS REPORT IS FOR ONE (1) TI PRCTRD ROD L 5.5MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT: (B)(4).
Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema
MAUDE report 17940715 ↗
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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