EXPEDIUM 299704195Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034467320), received between Jan 10, 2020 and Aug 10, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Material Deformation; Scratched Material

  It was reported on (b)(6) 2026 that sagittal and coronal benders notched and bent. There was no surgical delay with no Patient Involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50197617 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THE SAGITTAL IN-SITU BENDER CHIPPED INTRAOPERATIVELY. THERE WAS NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696948 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THE SAGITTAL IN-SITU BENDER CHIPPED INTRAOPERATIVELY. THERE WAS NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694735 ↗
• MalfunctionMar 3, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN-SITU BENDER WAS SNAPPED AND ROD HOLDER BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21504058 ↗
• MalfunctionMar 3, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN-SITU BENDER WAS SNAPPED AND ROD HOLDER BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503888 ↗
• MalfunctionJan 3, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT NO FRAGMENTS WERE GENERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072356 ↗
• MalfunctionJan 5, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE IN-SITU BENDER¿S DISCHARGE PIECES ARE BENT. AS A RESULT, THE OPERATOR ALWAYS SLIPPED OFF WHEN BENDING THE ROD. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) SAGITTAL IN-SITU BENDER, LEFT THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13171879 ↗
• MalfunctionNov 5, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2020 DURING AN UNKNOWN PROCEDURE, THE SAGITTAL BENDERS BROKE ON THE TIP. THE X25 INSERTERS WERE ALSO ROUNDED AND CAUSED STRIPPING OF THE SET SCREWS. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE OUTCOME WAS NOT REPORTED. THIS REPORT IS FOR ONE (1) SAGITTAL IN-SITU BENDER, LEFT. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10794080 ↗
• MalfunctionJan 10, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SPINAL FUSION PROCEDURE ON (B)(6) 2019, THE TIP OF THE SAGITTAL IN-SITU BENDER BROKE DURING BENDING PROCESS. FRAGMENTS WERE GENERATED AND WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY REPORTED. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9575264 ↗