EXPEDIUM 286200240Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034210995), received between Jun 11, 2019 and Sep 5, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (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. 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.

• MalfunctionSep 5, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AUG 9, 2024, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT ITEM WAS FOUND TO BE OUT OF DRAWING SPECIFICATION, THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. ALL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED. THIS REPORT IS FOR ONE (1) TORQUE WRENCH HANDLE FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20150762 ↗
• MalfunctionSep 5, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE HOSPITAL, IT WAS OBSERVED THAT 2862-00-240, 7 NM T-HANDLE, WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION TORQUE TESTED LOW. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THE PRODUCT HAS BEEN QUARANTINED AND IS AVAILABLE AND IS BEING RETURNED TO THE REPAIR SITE. ALL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED. THIS REPORT IS FOR ONE (1) TORQUE WRENCH HANDLE FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20145993 ↗
• MalfunctionJul 11, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE TORQUE TEST FAILED DURING INSPECTION AT THE LOCAL DISTRIBUTION CENTER. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM TORQUE WRENCH HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19719919 ↗
• MalfunctionNov 3, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ROUTINE INSPECTION OF THE LOANER SET, IT WAS IDENTIFIED THAT THE TORQUE WRENCH HANDLE WAS OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED LOW. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM TORQUE WRENCH HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067087 ↗
• MalfunctionMay 24, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING ROUTINE INCOMING INSPECTION OF A LOANER SET WAS OBSERVED THAT MATERIAL TORQUE WRENCH HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THE PRODUCT HAS BEEN QUARANTINED AND IS AVAILABLE AND IS BEING RETURNED TO THE REPAIR SITE. A REPLACEMENT DEVICE HAS BEEN ORDERED. NO REPLACEMENT PRODUCT IS REQUIRED, AND NO SHIPPING LABEL IS REQUIRED FOR THE PRODUCT RETURN. ALL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED. THIS REPORT IS FOR ONE (1) TORQUE WRENCH HANDLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991613 ↗
• MalfunctionApr 26, 2021Calibration Problem; Material Twisted/Bent; Calibration Problem; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A REVISION SURGERY. DURING THE REVISION SURGERY, THE SURGEON WAS DOING AN EXPEDIUM 4.5 GROWING ROD REVISION. IT WAS NOTICED THAT HANDLES HAVE NOT BEEN CHANGED OVER 4 YEARS. THE SURGEON SUGGESTED TO CHANGE SFX TORQUE AND TORQUE WRENCH HANDLE. THEY¿RE NEED TO RECALIBRATE. A FEW SCREWDRIVERS HAVE BEEN STRIPPED IN LAST COUPLE OF MONTHS. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) TORQUE WRENCH HANDLE. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11725553 ↗
• MalfunctionDec 22, 2020Calibration Problem; Calibration Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED AN UNKNOWN DATE THAT THE ITEM WAS FOUND DAMAGED DURING REGULAR LOANER INSPECTION PROCESS FROM TORQUE TESTING PROCEDURE. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT ARE REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1)TORQUE WRENCH HANDLE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11057322 ↗
• MalfunctionDec 22, 2020Calibration Problem; Calibration Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED AN UNKNOWN DATE THAT THE ITEM WAS FOUND DAMAGED DURING REGULAR LOANER INSPECTION PROCESS FROM TORQUE TESTING PROCEDURE. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT ARE REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) TORQUE WRENCH HANDLE THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11057243 ↗
• MalfunctionJun 11, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN (B)(6) 2019, THAT THE POINT OF TORQUE WRENCH SHAFT WAS SPINNING IN SET SCREW HEAD, THEY HAD TO CHANGE TO ALTERNATIVE INSTRUMENTS.. THERE WAS EVIDENCE OF WEAR AT THE HEX OF THE TORQUE SHAFT. IT IS UNKNOWN IF THERE WERE PROCEDURE AND PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 8689737 ↗