EXPEDIUM 279763860Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034201115), received between Sep 10, 2021 and Dec 31, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2024Break; Break

  IT WAS REPORTED THAT THE CUSTOMER DISCOVERED AFTER STERILIZATION (PRIOR TO PROCEDURE) THAT THE RUBBER STRIP ON THE INSITU BENDER FOR EXPEDIUM 6.35 P/N DS HAD BEEN RELEASED. THE INSTRUMENT IS ONE MONTH OLD. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO SURGICAL IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047364 ↗
• MalfunctionNov 8, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE 6.35 IN-SITU BENDERS DID NOT OPEN DURING ROD BENDING. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES (1) EXPEDIUM SPINE SYSTEM SAGITTAL BENDERS LEFT 6.35. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12772575 ↗
• MalfunctionNov 8, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE 6.35 IN-SITU BENDERS DID NOT OPEN DURING ROD BENDING. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES 1 EXPEDIUM SPINE SYSTEM SAGITTAL BENDERS LEFT 6.35. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771971 ↗
• MalfunctionSep 10, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE THE SAGITTAL BENDER TIP BENT. THE BEND BECAME TOO WIDE TO GRASP THE ROD. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR A SAGITTAL BENDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12455959 ↗