EXPEDIUM 179912090Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 6.35 x 10 x 90mm · 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 10705034085678), received between Sep 30, 2022 and Sep 30, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (2 reports).
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
- Migration2
Patient problems
- Failure of Implant1
- Unspecified Tissue Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2022Migration; Migration
IT WAS REPORTED THAT ON (B)(6) 2022 PATIENT REQUIRED REVISION SPINE SURGERY DUE TO RODS PULLING OUT OF THE SCREW HEADS AT THE BILATERAL PELVIC LEVEL. THERE WAS PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) EXP 6.35 TI POLY 10 X 90MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Failure of Implant
MAUDE report 15520635 ↗InjurySep 30, 2022Migration; Migration
IT WAS REPORTED THAT ON (B)(6) 2022 PATIENT REQUIRED REVISION SPINE SURGERY DUE TO RODS PULLING OUT OF THE SCREW HEADS AT THE BILATERAL PELVIC LEVEL. THERE WAS PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) EXP 6.35 TI POLY 10 X 90MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Unspecified Tissue Injury
MAUDE report 15520437 ↗
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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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