EXPEDIUM 179732535Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034073682), received between May 20, 2022 and Dec 7, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Migration” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 7, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A SPINAL FUSION (TH8 TO L3) FOR THE THORACOLUMBAR VERTEBRAE ON (B)(6) 2022. DURING INSERTION OF THE ROD, BACK-OUT OF THE SIX SCREWS IN QUESTION OCCURRED AT L1 TO L3. IT SEEMED THAT BONE QUALITY WAS DECLINING BECAUSE OF THE PATIENT AGE. SCREWS WERE REINSERTED BY INCREASING THE SCREW SIZE OR CHANGING THE TRAJECTORY OF THE INSERTION HOLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SI POLYAXIAL EXTEND TAB 5.5 X 5 X 35MM. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931474 ↗
• MalfunctionDec 7, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A SPINAL FUSION (TH8 TO L3) FOR THE THORACOLUMBAR VERTEBRAE ON (B)(6) 2022. DURING INSERTION OF THE ROD, BACK-OUT OF THE SIX SCREWS IN QUESTION OCCURRED AT L1 TO L3. IT SEEMED THAT BONE QUALITY WAS DECLINING BECAUSE OF THE PATIENT AGE. SCREWS WERE REINSERTED BY INCREASING THE SCREW SIZE OR CHANGING THE TRAJECTORY OF THE INSERTION HOLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SI POLYAXIAL EXTEND TAB 5.5 X 5 X 35MM. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931473 ↗
• MalfunctionMay 20, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PSF (TH11) FOR TREATING IDIOPATHIC SCOLIOSIS ON (B)(6) 2022, THE SURGEON TRIED TO DEPLOY THE SETSCREW ONTO THE SI SCREW, THE TABS ON THE SI SCREW BECAME BENT AND CAUSED CROSS-THREADING. THE SURGEON BROKE THE TABS AND SEPARATED THEM FROM THE SI SCREW. HOWEVER, THIS TAB BREAKING RESULTED IN DAMAGE TO THE SI SCREW¿S THREADS. THE SURGEON DECIDED TO REPLACE THE SI SCREW. THE PROCEDURE WAS COMPLETED WITH A FIFTEEN MINUTE DELAY. THIS REPORT IS FOR A SI POLYAXL EXT TAB 5 X 35MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14453613 ↗