EXPEDIUM SFX 189401407Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034168142), received between Feb 12, 2026 and Feb 12, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

1 other recall cover devices cleared under the same FDA submission (K062196, K111136, K142460); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS A SPINAL FUSION PERFORMED ON (B)(6) 2026. AFTER DETERMINING THE SIZE OF THE CONNECTOR AND THE SURGEON TRIED TO INSTALL IT ON THE ROD, THE SURGEON POINTED OUT THAT IT "DOESN'T FIT PROPERLY ON THE ROD." CONSIDERING THE POSSIBILITY THAT THE SET SCREW HAD NOT BEEN LOOSENED SUFFICIENTLY, THE SURGEON RETURNED IT TO A STABLE TABLE AND USED A SCREWDRIVER TO CHECK THAT IT WAS LOOSE AGAIN BEFORE INSTALLING IT ON THE ROD. AFTER DETERMINING THE POSITION AND ATTEMPTING TO TIGHTEN IT WITH THE SCREWDRIVER, THE SURGEON POINTED OUT THAT "THE SET SCREW MAY BE LOOSE." THE SURGEON CHANGED THE SCREWDRIVER AND LIGHTLY TIGHTENED IT AGAIN, BUT IT STILL FELT LOOSE. BECAUSE THERE WAS A RISK THAT THE IMPLANT WOULD BE DIFFICULT TO REMOVE, THE SALES REPRESENTATIVE REQUESTED AN EXCHANGE AND USED A DIFFERENT PRODUCT, WHICH ALLOWED THE OPERATION TO BE COMPLETED WITHOUT ANY PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327540 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062196, K111136, K142460. 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