EXPEDIUM 279732150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034200217), received between Jul 10, 2020 and Apr 17, 2023 — classified as 1 injury, 1 malfunction.

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.

• InjuryApr 17, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT THE DRIVER TIP BROKE INTRA-OP. DURING SURGERY, WHILE WITHDRAWING THE DRIVER SHAFT AFTER LOADING THE SCREW, IT WAS FOUND THAT THE TIP OF DRIVER SHAFT WAS BROKEN AND REMAINED IN THE SCREW. WHEN THE SCREW WAS REPLACED WITH A NEW ONE, IT CAUSED A SMALL AMOUNT OF BLEEDING TO THE PATIENT, AND THE SURGERY ENDED NORMALLY. THE PATIENT'S STATUS IS GOOD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO MORE INFORMATION AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) DRIVER SHAFT-SI SCR W/EXT TABS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16756992 ↗
• MalfunctionJul 10, 2020Material 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 DRIVER SHAFT WAS DISCOVERED AS DAMAGED OR WORN. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM DRVR SHAFT SI SCR. W/EXT TABS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10260201 ↗