EXPEDIUM 299704320Recalls & reported problems

Summary

The FDA's MAUDE database contains 144 adverse event reports that list this exact device (DI 10705034467399), received between Aug 28, 2017 and Sep 24, 2026 — classified as 6 injuries, 138 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (99 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 25 most recent of 144 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Calibration Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889558 ↗
• MalfunctionSep 10, 2026Calibration Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718490 ↗
• MalfunctionSep 10, 2026Calibration Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718487 ↗
• MalfunctionMar 26, 2026Calibration Problem

  IT WAS REPORTED THAT THE TORQUE LIMITER TRIGGERED TOO EARLY DURING THE LOCKING OF THE EXPEDIUM VERSE SYSTEM SCREW DURING A SPINAL FUSION PROCEDURE. THE EVENT RESULTED IN A SURGERY DELAY OF APPROXIMATELY 10 MINUTES, BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATIVE TORQUE LIMITER AVAILABLE ON-SITE. THERE WERE NO ADDITIONAL MEDICAL INTERVENTION REQUIRED, AND NO IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24705833 ↗
• MalfunctionFeb 12, 2026Calibration Problem

  IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE OUT OF TOLERANCE DURING ON SITE TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327709 ↗
• MalfunctionFeb 3, 2026Calibration Problem

  IT WAS REPORTED THAT THE TORQUE DID NOT PASS INSPECTION AT THE LOCAL WAREHOUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248110 ↗
• MalfunctionJan 30, 2026Calibration Problem

  IT WAS REPORTED THE TORQUE LIMITING HANDLE FAILED THE TORQUE TEST DURING INSPECTION. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222593 ↗
• MalfunctionJan 27, 2026Calibration Problem

  IT WAS REPORTED THAT THE INSTRUMENT HAD WEAK TORQUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192792 ↗
• MalfunctionJan 27, 2026Calibration Problem

  IT WAS REPORTED THAT THE INSTRUMENT HAD WEAK TORQUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192787 ↗
• MalfunctionDec 16, 2025Calibration Problem; Calibration Problem

  TORQUE FAILED TORQUE TEST (VALUES OUT OF SPECIFICATION) DURING TESTING AT THE LOCAL WAREHOUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817052 ↗
• MalfunctionDec 5, 2025Calibration Problem; Material Twisted/Bent; Calibration Problem; Material Twisted/Bent

  IT WAS REPORTED THE DEVICES ARE WORN. IT WAS REPORTED THE DEVICES ARE WORN. TORQUE NOT SUFFICIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727314 ↗
• MalfunctionDec 5, 2025Calibration Problem; Material Twisted/Bent; Calibration Problem; Material Twisted/Bent

  IT WAS REPORTED THE DEVICES ARE WORN. IT WAS REPORTED THE DEVICES ARE WORN. TORQUE NOT SUFFICIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727193 ↗
• MalfunctionDec 5, 2025Calibration Problem; Material Twisted/Bent; Calibration Problem; Material Twisted/Bent

  IT WAS REPORTED THE DEVICES ARE WORN. IT WAS REPORTED THE DEVICES ARE WORN. TORQUE NOT SUFFICIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23726958 ↗
• MalfunctionDec 5, 2025Calibration Problem; Material Twisted/Bent; Calibration Problem; Material Twisted/Bent

  IT WAS REPORTED THE DEVICES ARE WORN. IT WAS REPORTED THE DEVICES ARE WORN. TORQUE NOT SUFFICIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23726884 ↗
• MalfunctionDec 1, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE FOLLOWING ITEM DID NOT MEET SPECIFICATIONS FOR TORQUE. THE ITEM WAS TESTED AND REMOVED FROM SET. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682117 ↗
• MalfunctionJul 21, 2025Calibration Problem; Calibration Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A POST OPERATIVE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555834 ↗
• MalfunctionMay 16, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT AT A JNJ FACILITY ON AN UNKNOWN DATE, SEVERAL INSTRUMENTS FAILED A TORQUE LIMITING TEST. THE DEVICES ARE OUT OF CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038577 ↗
• MalfunctionMay 16, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT AT A (B)(6) ON AN UNKNOWN DATE, SEVERAL INSTRUMENTS FAILED A TORQUE LIMITING TEST. THE DEVICES ARE OUT OF CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038493 ↗
• MalfunctionApr 2, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE PRODUCT FAILED TORQUE TEST DURING INSPECTION AT LOCAL DC. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21757588 ↗
• MalfunctionApr 2, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE PRODUCT FAILED TORQUE TEST DURING INSPECTION AT LOCAL DC. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21757252 ↗
• MalfunctionApr 1, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED DURING A SURGERY THE HANDLE WASN'T ABLE TO TORQUE THE SET SCREW OUT, MEANING THE SET SCREW WASN'T FINAL TIGHTENED PROPERLY. WE HAD TO OPEN ANOTHER SET TO USE THE T-HANDLE IN. NO PATIENT IMPACT. A SURGICAL DELAY OF A FEW MINUTES AS THE OTHER SET WAS OPENED.

  Patient problems: Insufficient Information

  MAUDE report 21741801 ↗
• MalfunctionMar 10, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2025. THE TORQUE HANDLE DOES NOT TORQUE ANYMORE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21562451 ↗
• MalfunctionMar 10, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2025. THE TORQUE HANDLE DOES NOT TORQUE ANYMORE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21562398 ↗
• MalfunctionMar 3, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THIS ITEMS HAS BEEN TESTED PRE-OPERATIVELY DURING THE TORQUE TESTING. IT HAS BEEN TESTED FOR MORE THAN 40 TIMES. JUST 3 TIMES ON RANGE; THE REST OUT OF RANGE. NOT USED DURING A PROCEDURE SO NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21504864 ↗
• MalfunctionFeb 24, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE TORQUE HANDLES DO NOT TORQUE ANYMORE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21451528 ↗