EXPEDIUM 299704140Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034467290), received between Aug 6, 2021 and Jul 16, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE DRIVER SHAFT WAS PLACED IN THE HANDLE AND IT COULD NOT BE LOCKED. THERE WAS NO CONSEQUENCE TO THE PATIENT. THE SURGERY WAS PERFORMED AS PLANNED. THE OTHER HANDLE IN THE SYSTEM WAS USED WITH NO DELAY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM TEAR-DROP HANDLE, RATCHETING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19754700 ↗
• MalfunctionNov 8, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED ON WEDNESDAY, OCTOBER 18TH, SETS WERE DROPPED OFF FOR CASES ON FRIDAY, OCTOBER 20TH. UPON RECEIPT OF THESE SETS, THERE WERE MULTIPLE INSTRUMENTS THAT WERE DUBBED UNFIT TO BE USED IN SURGERY (PART NUMBERS OF EACH INSTRUMENT HAVE BEEN INCLUDED). SPD RAN A BOROSCOPE DOWN EACH OF THE CANNULATED INSTRUMENTS (WHICH WE AS REPS DO NOT HAVE ACCESS TO AT ANY OF OUR ACCOUNTS TO CHECK THESE OURSELVES), AND FOUND MULTIPLE INSTRUMENTS THAT FELL OUTSIDE OF THEIR GUIDELINES FOR SAFE USE IN SURGERY. SUBSEQUENTLY, I HAD TO RUN TO MULTIPLE DIFFERENT HOSPITALS AROUND DENVER TO BE ABLE TO MAKE THESE SETS COMPLETE AND USABLE. THIS PUT ME OUTSIDE OF THE GUIDELINES PUT IN PLACE BY THE VA IN TERMS OF TIMELINESS ON DROPPING OFF THE TRAYS. EVENT OCCURRED DURING STERILE PROCESSING AND FIELD INSPECTION. THERE WERE PATIENT OUTCOMES OR CONSEQUENCES. ONE OF THE TWO CASES SCHEDULED HAD TO BE CANCELLED THIS REPORT IS FOR ONE (1) TEAR-DROP HANDLE, RATCHETING THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18096890 ↗
• MalfunctionNov 8, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED ON WEDNESDAY, OCTOBER 18TH, SETS WERE DROPPED OFF FOR CASES ON FRIDAY, OCTOBER 20TH. UPON RECEIPT OF THESE SETS, THERE WERE MULTIPLE INSTRUMENTS THAT WERE DUBBED UNFIT TO BE USED IN SURGERY (PART NUMBERS OF EACH INSTRUMENT HAVE BEEN INCLUDED). SPD RAN A BOROSCOPE DOWN EACH OF THE CANNULATED INSTRUMENTS (WHICH WE AS REPS DO NOT HAVE ACCESS TO AT ANY OF OUR ACCOUNTS TO CHECK THESE OURSELVES), AND FOUND MULTIPLE INSTRUMENTS THAT FELL OUTSIDE OF THEIR GUIDELINES FOR SAFE USE IN SURGERY. SUBSEQUENTLY, I HAD TO RUN TO MULTIPLE DIFFERENT HOSPITALS AROUND DENVER TO BE ABLE TO MAKE THESE SETS COMPLETE AND USABLE. THIS PUT ME OUTSIDE OF THE GUIDELINES PUT IN PLACE BY THE VA IN TERMS OF TIMELINESS ON DROPPING OFF THE TRAYS. EVENT OCCURRED DURING STERILE PROCESSING AND FIELD INSPECTION. THERE WERE PATIENT OUTCOMES OR CONSEQUENCES. ONE OF THE TWO CASES SCHEDULED HAD TO BE CANCELLED. THIS REPORT IS FOR ONE (1) TEAR-DROP HANDLE, RATCHETING. THIS IS REPORT 3 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18096872 ↗
• MalfunctionAug 6, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, IT WAS FOUND THAT THE TEAR DROP HANDLE WAS UNABLE TO BE ATTACHED TO AN UNKNOWN INSERTER. THE ISSUE WAS DISCOVERED PREOPERATIVELY. THE SPINO-PELVIC FUSION WAS COMPLETED ON (B)(6) 2021 USING A REPLACEMENT DEVICE. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) TEAR-DROP HANDLE, RATCHETING. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12287963 ↗