EXPEDIUM 279788955Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034203362), received between Feb 1, 2021 and Jun 6, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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.

• MalfunctionJun 6, 2023No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A BLIND UNIT WAS RECEIVED IN LOCAL STOCK MARKED WITH RED TAPE. UPON MANUFACTURER INVESTIGATION IT WAS DETERMINED THAT A PEDICLE PROBE HAD A BROKEN TIP AND A DEROTATION STICK HAD ONE OF ITS CLAMP YOKES BROKEN OFF. THIS REPORT IS FOR AN EXP 5.5 DEROTATION QCK STICK F. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17074934 ↗
• MalfunctionFeb 1, 2021Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED THAT A QUICK STICK AND DEROTATION RACK WAS STICKING BETWEEN RACK AND THE QUICK STICK. IT WAS NOT DEFINED WHICH PIECE IS CAUSING IT TO STICK. ANOTHER QUICK STICK AND DE-ROTATION RACK WAS USED TO COMPLETE THE SUCCESSFUL PROCEDURE. NO OTHER DETAILS WERE GIVEN. CONCOMITANT PRODUCT: EXP5.5 DEROTATION QUICK STICK, LOT #MI71013, QTY UNKNOWN. EXP 5.5 DEROTATION QCK STICK F, LOT/QTY UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) EXP 5.5 DEROTATION QCK STICK F THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11258621 ↗