EXPEDIUM 299704200Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034467337), received between Feb 6, 2019 and Dec 2, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 23694797 ↗
• 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 23694756 ↗
• 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 21503938 ↗
• 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 21503842 ↗
• MalfunctionNov 29, 2023Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A POSTERIOR FUSION FOR HIP PAIN ON 07-NOVEMBER-2023, THE TIP OF THE BENDER IN QUESTION BROKE OFF. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SAGITTAL IN-SITU BENDER, RIGHT 5.5. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18233384 ↗
• 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 (2) DEVICES. THIS REPORT IS FOR (1) SAGITTAL IN-SITU BENDER, RIGHT. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13171901 ↗
• 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, RIGHT. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10794382 ↗
• MalfunctionOct 10, 2019Break; Break

  DURING AN AIS CORRECTION WITH EXPEDIUM VERSE DR. (B)(6) PERFORMED SOME IN-SITU BENDING OF THE COCR RODS AFTER THEY WERE FULLY SEATED IN THE SCREWS AND ALL SET SCREWS WERE FINAL TIGHTENED. DURING THE BENDING OF THE SECOND ROD THE IN-SITU BENDER BROCK. NO PATIENT HARM OCCURRED AND THE PROCEDURE COULD BE COMPLETED BY USING THE OTHER SIDE OF THE ROD BENDER. IN ADDITION, DURING THE SCREW LOADING ON THE SCREW DRIVER, IT DISASSEMBLED ITSELF. THE SCREW DRIVER SHAFT UNLOCKED ITSELF FROM THE OUTER SLEEVE WHEN LOADING THE SCREW. SPECIFICALLY THE SCREW DRIVER SHAFT GOT PUSHED OUT OF THE SLEEVE DISTALLY DURING THE LAST TURNS OF LOADING THE SCREW. THE NURSE WAS ABLE TO RE-CREATE THE DISASSEMBLY BY JUST PULLING AND SIMULTANEOUSLY ROTATING THE SCREW DRIVER SHAFT IN THE SLEEVE. IT SEEMS THE RETAINING MECHANISM OF THE OUTER SLEEVE IS DAMAGED / WORN. TO COMPLETE INSERTION OF THE SCREWS WE JUST USED THE 2ND SCREW DRIVER FROM THE SET. IF OTHER, DESCRIBE: REVISION SURGERY OF PREVIOUS AIS CORRECTION WITH EXPEDIUM DIFAR DUE TO PROGRESSING LUMBAR CURVE BELOW THE INITIAL CONSTRUCT., WAS SURGERY DELAYED DUE TO THE REPORTED EVENT?: NO, ACTION TAKEN WHEN EVENT OCCURRED?: USED THE OTHER SIDE OF THE INSTRUMENT,

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9174478 ↗
• MalfunctionFeb 6, 2019Break; Break

  IT WAS REPORTED THAT THE SURGEON HAD 3 INSTRUMENTS BREAK DURING A T3-ILIUM REVISION SPINAL FUSION. ALL INSTRUMENTS BROKE WHILE THE SURGEON WAS USING THEM TO PREFORM VARIOUS FUNCTIONS IN THE CASE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN. WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES? NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? NO. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8309947 ↗