EXPEDIUM 179799750Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034083834), received between Jan 5, 2022 and Jan 5, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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

Recent adverse event reports

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

• MalfunctionJan 5, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2020, THE PATIENT UNDERWENT REVISION SPINAL SURGERY TREATING L4-S1. THE SURGEON EXPERIENCE DIFFICULTY REMOVED THE S1 SCREW AS THE DRIVER WAS UNABLE TO EFFECTIVE ENGAGE WITH THE SCREW. THE SCREW WAS FOUND THE BE STRIPPED AND WORN DOWN. THE SCREW HEAD WAS EVENTUALLY MOBILIZED AND ENABLED REMOVAL OF THE SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS RELATED TO (B)(4). THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 X 7 X 50MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13170981 ↗