EXPEDIUM 179712740SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034267081), received between Dec 13, 2023 and Mar 12, 2024 — classified as 2 injuries, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRODUCT REMAINS INSITU IN PATIENT. THE PATIENT IS STABLE.

  Patient problems: Osteolysis

  MAUDE report 18885759 ↗
• InjuryMar 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRODUCT REMAINS INSITU IN PATIENT. THE PATIENT IS STABLE.

  Patient problems: Osteolysis

  MAUDE report 18885753 ↗
• MalfunctionMar 12, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN IRELAND AS FOLLOWS: IT WAS REPORTED THAT THE REVISION FUSION WAS UNDERTAKEN AND ALL EXISTING INNER SET SCREWS AND RODS WERE REMOVED. ALL SCREWS APPEARED INTACT, AND THE SURGEON PULLED ON EACH SCREW TO DOUBLE CHECK INTEGRITY. UPON PULLING ON THE SCREW AT L3 ON THE LEFT SIDE, THE POLYAXIAL COMPONENT CAME AWAY. THE SURGEON PROCEEDED TO INSERT NEW SCREWS CAUDALLY AND CRANIALLY AND OPTED TO LEAVE THE DISTAL SCREW SHAFT IN SITU. REVISION SURGERY WAS PERFORMED TO TREAT ADJACENT SEGMENT ISSUES BY INSERTING NEW SCREWS CAUDALLY AND CRANIALLY. THE DISTAL COMPONENT OF THE BROKEN SCREW REMAINED IN THE PATIENT. THERE WAS A CONSEQUENCE FOR THE PATIENT DUE TO THE EVENT, AS IT RESULTED IN A SECOND PROCEDURE. A BROKEN COMPONENT OF THE SCREW REMAINED IN THE PATIENT. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) SI POLYAXL SCREW 7 X 40MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18884848 ↗
• MalfunctionDec 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SWEDEN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON 21-NOVEMBER-2023, AN EXPEDIUM SCREW WAS PLACED ON THE EXPEDIUM SCREWDRIVER. WHEN INSERTING THE SCREW INTO THE PEDICLE THE SCREWDRIVER BROKE, AND THE TIP OF THE SCREWDRIVER REMAINED STUCK IN THE SCREW HEAD. THE SCREW WAS REMOVED USING OTHER DEVICES AND WAS REPLACED BY A NEW SCREW USING ANOTHER SCREWDRIVER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 5 MINUTES. THERE WAS NO ADVERSE PATIENT IMPACT. ALL GENERATED FRAGMENTS WERE REMOVED WITHOUT ADDITIONAL MEDICAL INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 7 X 40MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318331 ↗