EXPEDIUM 179798100Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM CLOSED CONNECTOR 5.5 100mm · Class 2 · Implant
Data updated Oct 13, 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 10705034083032), received between Oct 22, 2019 and Oct 22, 2019 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Tissue Damage1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS IS A REVISION CASE REPORT. THE 8 MM SCREW AND ILIAC CONNECTOR FROM THE RIGHT SIDE WERE REMOVED DUE TO PROTRUSION WHICH RESULTED IN PENETRATION OF THE SKIN OF THE PATIENT AND INFECTION. THE PRIMARY SURGERY WAS DONE IN (B)(6) 2019. THE PATIENT HAS LOST 20 KG OF BODY WEIGHT IN THE LAST 5 MONTHS AND IS A HEAVY SMOKER. THE PROTRUSION OF THE SCREW WAS NOT EVIDENT AT THE TIME OF THE SURGERY. THE PRODUCTS INVOLVED HAD TO BE LEFT IN THE HOSPITAL FOR STERILIZATION (CODE 1997-21-8XX AND 1997-21-000) AND MIGHT BE RETURNED FOR ANALYSIS IF THE HOSPITAL ALLOWS . I WILL HAVE THAT INFORMATION ON MONDAY, 30TH SEPTEMBER. CODE 1797-98-100 WILL NOT BE RETURNED AS IT WILL BE USED FOR ANALYSIS OF THE INFECTION (SONIFICATION). THIS COMPLAINT INVOLVE THREE (3) DEVICES.
Patient problems: Tissue Damage; Unspecified Infection
MAUDE report 9217630 ↗
Other Pedicle screw spinal system, adolescent idiopathic scoliosis devices
- CD HORIZON® Spinal System 5540030Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis230 reports
- CD HORIZON® Spinal System 7578302Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis122 reports
- EXPEDIUM 179762480Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis114 reports
- ReLine 13550000Nuvasive, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis55 reports
- CD HORIZON® Spinal System 5440030Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis50 reports
- EXPEDIUM 179712640Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis28 reports
- EXPEDIUM VIPER 196789300Depuy Spine, LLC · Pedicle screw spinal system, adolescent idiopathic scoliosis18 reports
- EXPEDIUM 179788635Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis18 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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