EXPEDIUM 279722550Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034199382), received between Jul 25, 2017 and Jul 11, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE EXPEDIUM CASTLENUT TIGHTENER TIPS HAD BROKEN OFF. PATIENT STATUS, OUTCOME, AND CONSEQUENCES ARE UNKNOWN. THIS REPORT IS FOR ONE (1) XPDM DI INTERMEDT CASTLE TIGHT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298669 ↗
• MalfunctionJun 6, 2019Break; Break

  IT WAS REPORTED ON (B)(6) 2019, DURING THE TRANSFORAMINAL LUMBAR INTERBODY FUSION SURGERY WITH EXPEDIUM DUAL INNIE FOR DEGENERATIVE LUMBAR SCOLIOSIS AT L2, THE SURGEON PERFORMED FINAL TIGHTENING OF DUAL INNIE SET SCREW. IT WAS FOUND OUT THAT THE TIP OF THE TIGHTENER WAS BROKEN. ALTHOUGH, THE SURGERY WAS COMPLETED WITHOUT REPORTED ANY PROBLEM. THERE WAS NO SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8675569 ↗
• MalfunctionMar 11, 2019Break; Break

  THE FOLLOWING WAS REPORTED: L3-S1 REVISION FUSION CHANGE L: (B)(6) PRIVATE HOSPITAL, (B)(6) 2019. X25 DRIVERS WERE NOT IN GREAT CONDITION, TO BEGIN WITH - AND STRIPPED THE WHOLE SURGEON WAS DRIVING S1 LEFT THE SCREW IN LAST FEW TURNS. ALSO COULD NOT USE ANY DRIVERS SAFELY FOR FINAL LOCKING, HAD TO FINAL LOCK WITH A LOT OF DOWNWARD FORCE AND TORQUE INTERMEDIATE DRIVER BROKE WHILE EX PLANTING SET SCREW. NO AE TO THE PATIENT, NO DELAY IN THE SURGERY. FEMALE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8408245 ↗
• MalfunctionJul 25, 2017Break; Break

  ON TIGHTENING OF THE DI NUT, THE TIP (TEETH) OF THE CASTLE TIGHTENER SNAPPED OFF. THIS HAPPENED ALSO ON THE SECOND AFTER I HAD REMINDED THE SURGEON THAT THIS TIGHTENER DIDN¿T TORQUE OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6741650 ↗
• MalfunctionJul 25, 2017Break; Break

  ON TIGHTENING OF THE DI NUT, THE TIP (TEETH) OF THE CASTLE TIGHTENER SNAPPED OFF. THIS HAPPENED ALSO ON THE SECOND AFTER I HAD REMINDED THE SURGEON THAT THIS TIGHTENER DIDN¿T TORQUE OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6741389 ↗