EXPEDIUM 189602000Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM SINGLE INNIE SET SCREW 6.35 · 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 10705034171579), received between Sep 20, 2018 and Sep 20, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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
- Loose or Intermittent Connection1
Patient problems
- Spinal Column Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 20, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT DR. (B)(6) WAS DOING A REVISION ON THE PATIENT ON MONDAY (B)(6) 2018, HE IMPLANTED ANOTHER ROD WITH OPEN 6.35 CONNECTORS. THIS IMPLANTATION PROCEDURE WAS UNILATERAL. UPON EXPLORATION, HE SAW THE SET SCREW WAS EXTREMELY LOOSE. ONCE HE GAINED BETTER EXPOSURE, HE SAW THE THREADED AREA OF THE LATERAL CONNECTOR SPLAYED. AFTER REMOVING THE LATERAL CONNECTOR, HE SAW THE BASE CRACKED. DR. (B)(6) REPLACED THE CONNECTOR WITH A NEW ONE. (1896-92-050).
Patient problems: Spinal Column Injury
MAUDE report 7894549 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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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