EXPEDIUM 179722150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034070162), received between Sep 5, 2018 and Sep 29, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) AT S1 TREATING SPONDYLOLISTHESIS, THE SCREWDRIVER TIP BROKE OFF DURING SCREW INSERTION. FRAGMENT(S) BECAME STUCK WITH THE SCREWS SHAFT. THE SURGEON REMOVED THE SCREW AND COMPLETED THE PROCEDURE WITH REPLACEMENTS. THERE WAS A, LESS THAN, 30-MINUTE SURGICAL DELAY. ALL THE FRAGMENTS WERE REMOVED WITH THE SCREW. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 X 10 X 50MM THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10599455 ↗
• InjurySep 5, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2018, THE TLIF SURGERY FOR LUMBAR SPONDYLOLISTHESIS WAS PERFORMED BY USING THE EXPEDIUM SYSTEM. THE FIXED SITE WAS L5 ¿ S1. DURING THE SURGERY, DUE TO AN EXCESSIVE INSERTING TORQUE, THE TIP OF THE DRIVER (279722400) GOT BROKEN AND THE BROKEN TIP WAS LEFT IN THE HEAD OF THE SCREW (EITHER 179722145 OR 179722150), WHICH RESULTED IN THE INSERTION FAILURE. THE SCREW IN QUESTION WAS EXTRACTED AND THEN A NEW SCREW WAS INSERTED. NO BROKEN PIECES WERE FOUND LEFT IN THE PATIENT¿S BODY UNDER THE X-RAY. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A 60-MINUTE DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE SURGEON HAS REQUESTED US TO MAKE AN IN-DEPTH INVESTIGATION INCLUDING A POSSIBILITY OF METALLIC FATIGUE.

  Patient problems: Not Applicable

  MAUDE report 7847778 ↗