EXPEDIUM 179799755Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034083841), received between Oct 31, 2019 and Dec 11, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RODS FRACTURED AT T12 LEVEL AND SCREWS BROKEN AT L5 LEVEL. REVISION SURGERY TO REPLACE RODS AND EXTEND CONSTRUCT TO S1 AND PELVIS WAS PERFORMED. NO PROBLEMS DURING PROCEDURE. THIS REPORT IS FOR ONE (1) EXP DI FAR SCREWS 7.00 X 55. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9452908 ↗
• InjuryOct 31, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RODS FRACTURED AT T12 LEVEL AND SCREWS BROKEN AT L5 LEVEL. REVISION SURGERY TO REPLACE RODS AND EXTEND CONSTRUCT TO S1 AND PELVIS WAS PERFORMED. NO PROBLEMS DURING PROCEDURE. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9261790 ↗