EXPEDIUM 188112665Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034146850), received between Dec 1, 2017 and Dec 1, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K041119, K111136); they may or may not involve this specific model.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2017Break; Break

  THE HEAD OF THE SCREW HAD BROKEN OFF RIGHT AT THE NECK OF THE SCREW. THE PATIENT WAS RETURNING FOR REVISION OF THESE BROKEN SCREWS AT S1 BILATERALLY.

  Patient problems: Spinal Column Injury

  MAUDE report 7074567 ↗
• InjuryDec 1, 2017Break; Break

  THE HEAD OF THE SCREW HAD BROKEN OFF RIGHT AT THE NECK OF THE SCREW. THE PATIENT WAS RETURNING FOR REVISION OF THESE BROKEN SCREWS AT S1 BILATERALLY.

  Patient problems: Spinal Column Injury

  MAUDE report 7074526 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041119, K111136. One submission often covers many models, so check the product and lot details in each record.

• Z-1674-2015 · Apr 21, 2015 · Terminated
  EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467