EXPEDIUM TOP NOTCH 279712525Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034198972), received between Jun 30, 2021 and Aug 21, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 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.

• MalfunctionAug 21, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. WHEN REDUCING THE ROD INTO THE SET SCREW, A REDUCTION TOOL WAS REQUIRED. THE KERRISON STYLE ONE FROM THE EXPEDIUM 5.5 CORE INSTRUMENT SET WAS USED. THIS BECAME JAMMED ON THE SCREW TULIP AND DID NOT PERFORM IT¿S FUNCTION AS A ROD REDUCER. IT WAS EXTREMELY DIFFICULT TO REMOVE FROM THE TULIP AND IN DOING SO THE PATIENTS SKIN WAS CAUGHT UP IN THE STRUGGLE TO REMOVE AND WAS SLIGHTLY CUT. THE DEVICE WAS EVENTUALLY REMOVED, AND THE CASE WAS COMPLETED WITHOUT FURTHER COMPLICATION. THIS REPORT IS FOR A ROD APPROX W/DOVETAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20012629 ↗
• MalfunctionMar 23, 2023Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM DEPUY REPORTS AN EVENT IN SINGAPORE AS FOLLOWS: IT WAS REPORTED THAT ROD APPROXIMATOR FROM EXPEDIUM SET WAS JAMMED ON THE SCREWHEAD AND COULD NOT BE REMOVED. SURGEON HAD TO BREAK IT IN ORDER TO RELEASE IT. THERE WAS SURGICAL DELAY OF 120 MINUTES DUE TO THE REPORTED EVENT. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) ROD APPROX W/DOVETAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600917 ↗
• MalfunctionFeb 15, 2023Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS DISCOVERED PREOPERATIVELY THAT THE DEVICES WERE BROKEN. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SQUEEZE-HANDLE ROD APPROXIMATOR FOR TOP NOTCH 5.5. THIS IS REPORT 13 OF 13 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378165 ↗
• MalfunctionJun 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12095559 ↗