EXPEDIUM 279722460Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034199368), received between May 21, 2020 and Jul 28, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED POST OPERATIVELY ON (B)(6) 2023 THE DI REDUCTION TUBE/INSERTER ARE NOT EASILY PUT TOGETHER. OFTEN GET STUCK. MAY BE BENT SO THE INSERTER DOESN'T FIT DOWN THE TUBE. NO PATIENT CONSEQUENCES. NO DELAY TO SURGERY. THIS REPORT IS FOR ONE XPDM DI REDUCTION TUBE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413919 ↗
• MalfunctionJul 28, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED POST OPERATIVELY ON (B)(6) 2023, THE DI REDUCTION TUBE/INSERTER ARE NOT EASILY PUT TOGETHER. OFTEN GET STUCK. MAY BE BENT SO THE INSERTER DOESN¿T FIT DOWN THE TUBE. NO PATIENT CONSEQUENCES. NO DELAY TO SURGERY. THIS REPORT IS FOR ONE XPDM DI REDUCTION TUBE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413839 ↗
• MalfunctionJul 28, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED POST OPERATIVELY ON (B)(6) 2023 THE DI REDUCTION TUBE/INSERTER ARE NOT EASILY PUT TOGETHER. OFTEN GET STUCK. MAY BE BENT SO THE INSERTER DOESN¿T FIT DOWN THE TUBE. NO PATIENT CONSEQUENCES. NO DELAY TO SURGERY THIS REPORT IS FOR ONE XPDM DI REDUCTION TUBE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413739 ↗
• MalfunctionJul 28, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED POST OPERATIVELY ON (B)(6) 2023 THE DI REDUCTION TUBE/INSERTER ARE NOT EASILY PUT TOGETHER. OFTEN GET STUCK. MAY BE BENT SO THE INSERTER DOESN¿T FIT DOWN THE TUBE. NO PATIENT CONSEQUENCES. NO DELAY TO SURGERY THIS REPORT IS FOR ONE XPDM DI REDUCTION TUBE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413669 ↗
• MalfunctionMay 21, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE HOSPITAL CALLED TO REPORT THAT DURING SPINE PROCEDURE, A NUMBER OF INSTRUMENTS ON A CONSIGNMENT KIT, BROKE AND THE HOSPITAL DISCARDED ITEMS, WILL BE UNABLE TO BE RETURNED. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1) XPDM DI REDUCTION TUBE. THIS REPORT IS 3 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10080630 ↗