EXPEDIUM 179788745Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034081571), received between Oct 18, 2019 and Sep 10, 2024 — classified as 3 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2024Break; Break

  IT WAS REPORTED THAT THIS WAS A SPINAL FUSION (T4-L4) FOR AIS (TYPE6) ON (B)(6) 2024. IN THE SURGERY, AFTER ALMOST ALL THE SCREWS WERE INSERTED AND THE ROD ASSEMBLED, THE SURGEON FELT DISCOMFORT WITH THE HEAD OF L4 RIGHT SCREW. THEREFORE, THE SURGEON REMOVED THE L4 RIGHT SCREW TO CHECK IT AND FOUND THAT THE HEAD WAS BROKEN. A NEW SCREW WAS INSERTED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) EXP TI UNI SCREW 7MM X 45MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20184139 ↗
• MalfunctionJan 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE THE SURGEON WAS REDUCING THE ROD AND NOTICED THAT THE SET SCREW WOULD NOT SEAT INTO THE HEAD OF THE SCREW. UPON FURTHER EXAMINATION, IT WAS NOTED THAT THE SCREW HEAD INNER SADDLE HAD SOMEHOW RISEN UP INTO THE TULIP OF THE SCREW WHICH WAS PREVENTING THE ROD FROM BEING REDUCED. THIS MAY HAVE HAPPENED WHEN THE SURGEON WAS ROTATING THE HEADS OF THE SCREWS WITH A COBB ELEVATOR INSTEAD OF THE HEAD TURNER. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: SET SCREWS (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1), ROD (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9575763 ↗
• MalfunctionOct 18, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  REVISION FUSION: (B)(6) HOSPITAL, (B)(6) 2019. PRIMARY IMPLANT DATE: (B)(6) 2018. THREAD WAS DAMAGED WHEN REDUCING ROD TO SCREW HEAD USING FLEX CLIP REDUCER. REPLACED THE SCREW WITH A POLYAXIAL SCREW. NO AE REPORTED. 5-10 MINUTES DELAY IN THE SURGERY.

  Patient problems: Not Applicable

  MAUDE report 9209195 ↗