EXPEDIUM 279722500Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034199375), received between Mar 2, 2022 and Nov 14, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON NOVEMBER 4 2024, THE END OF THE STABILIZER HAS SPLAYED AND WAS SLIPPING ON THE ROD. THIS OCCURRED DURING THE PROCEDURE. ANOTHER SET WAS OPENED AND USED. THERE WAS NO IMPACT TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20682878 ↗
• MalfunctionNov 28, 2023Break; Break

  IT WAS REPORTED THAT ON NOVEMBER 3, 2023, THE SURGEONS WERE USING THE COUNTER TORQUE FOR THE EXPEDIUM 5.5 SYSTEM, AND THE TEETH OF THE COUNTER TORQUE WAS SPLAYED OPEN. THERE WAS NO PATIENT CONSEQUENCE REPORTED, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE PATIENT WAS DISCHARGED HOME. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM ROD STABILIZER DI. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18217676 ↗
• MalfunctionMay 17, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, A TEAR ON THE HANDLE OF THE EXPEDIUM ROD STABILIZER WAS NOTICED DURING POST OP INSPECTION. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) DI ROD STABILIZER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16947739 ↗
• MalfunctionMay 7, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, UPON RESTOCKING A SET, IT WAS NOTICED ON THE ANTI-TORQUE ROB STABILIZER DEVICE THAT THE TABS HAD SPLAYED. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DI ROD STABILIZER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14321627 ↗
• MalfunctionMar 2, 2022Break; Device Slipped; Break; Device Slipped

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE, THE SURGEON WAS USING THE ROB STABILIZER AND NOTED IT FELT LOOSE AND WAS TOGGLING ON THE HEAD OF THE SCREW. ON INSPECTION, THE INSTRUMENT TIP AT POINT OF CONTACT WITH THE ROD WAS SPLAYED. IT WAS NOTED THERE WAS NO SURGICAL DELAY AND NO MALFUNCTION OF THE SCREW OR ROD. THIS REPORT IS FOR A ROD STABILIZER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13652730 ↗