EXPEDIUM 179732755Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034074061), received between Sep 7, 2023 and Sep 7, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 7, 2023Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT SPINAL FUSION FOR MOB. DURING THE PROCEDURE, IT WAS FOUND THAT THE 7X55MM SCREW COULD NOT BE ATTACHED TO THE SCREWDRIVER PROPERLY. THE SURGEON TRIED WITH ANOTHER SCREW OF THE SAME TYPE, BUT THE NEW SCREW COULD NOT BE ATTACHED STRAIGHT TO THE SCREWDRIVER. NO ADDITIONAL SCREWS OF THIS TYPE WERE AVAILABLE, SO THE PROCEDURE WAS CONTINUED USING A 9X55MM SCREW. UPON CHECKING THE SCREWDRIVER, IT WAS FOUND THAT THE TIP HAD BROKEN OFF AND REMAINED STUCK IN ONE OF THE 7X55MM SCREWS. THIS FRAGMENT WAS EXTRACTED FROM THE PATIENT WITH NO ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SI POLYAXIAL EXTEND TAB 5.5 X 7.0 X 55MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17699952 ↗
• MalfunctionSep 7, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT SPINAL FUSION FOR MOB. DURING THE PROCEDURE, IT WAS FOUND THAT THE 7X55MM SCREW COULD NOT BE ATTACHED TO THE SCREWDRIVER PROPERLY. THE SURGEON TRIED WITH ANOTHER SCREW OF THE SAME TYPE, BUT THE NEW SCREW COULD NOT BE ATTACHED STRAIGHT TO THE SCREWDRIVER. NO ADDITIONAL SCREWS OF THIS TYPE WERE AVAILABLE, SO THE PROCEDURE WAS CONTINUED USING A 9X55MM SCREW. UPON CHECKING THE SCREWDRIVER, IT WAS FOUND THAT THE TIP HAD BROKEN OFF AND REMAINED STUCK IN ONE OF THE 7X55MM SCREWS. THIS FRAGMENT WAS EXTRACTED FROM THE PATIENT WITH NO ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SI POLYAXIAL EXTEND TAB 5.5 X 7.0 X 55MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17699949 ↗