EXPEDIUM 279763865Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034201122), received between Sep 10, 2021 and May 15, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE FOR KYPHOSIS CORRECTION ON (B)(6) 2023, WHEN THE SURGEON WAS TRYING TO BEND THE ROD IN SITU USING THE INSITU ROD BENDERS, THEY KEPT SLIPPING ON THE ROD. UPON INSPECTION, IT WAS NOTED THAT THE END THAT HOLDS THE ROD HAD BECOME BENT. ROD HOLDERS WERE USED AS AN ALTERNATIVE. THERE WAS NO IMPACT TO THE PATIENT DUE TO THE FAILURE. THE PATIENT WAS REPORTED TO BE DOING WELL AFTER SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SAGITTAL BENDERS RIGHT 6.35. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929205 ↗
• MalfunctionNov 8, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE INSITU BENDER SPLAYED OPEN DURING ROD BENDING. SURGICAL DELAY IS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) SAGITTAL BENDER (R). THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775560 ↗
• MalfunctionNov 8, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE INSITU BENDER SPLAYED OPEN DURING ROD BENDING. SURGICAL DELAY IS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) SAGITTAL BENDER (R). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775533 ↗
• MalfunctionSep 10, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE TOP OF INSIGHTU BENDER WAS TOO BENT TO GRASP THE ROD PROPERLY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART # UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM SAGITTAL BENDERS RIGHT 6.35. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12456296 ↗