EXPEDIUM 179722640Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034070629), received between Jun 14, 2018 and Aug 26, 2021 — classified as 6 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD SUFFERED FROM THE ADJACENT DISEASE. ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED WITHOUT FURTHER ISSUE. THE PRIMARY PROCEDURE WAS PERFORMED IN 2008 AND EXPEDIUM DI WAS APPLIED. THIS COMPLAINT INVOLVES TWENTY (20) DEVICES. THIS REPORT INVOLVES ONE (1) EXP DI POLYAXL SCRW 6 X 40MM. THIS IS REPORT 15 OF 20 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12374603 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD SUFFERED FROM THE ADJACENT DISEASE. ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED WITHOUT FURTHER ISSUE. THE PRIMARY PROCEDURE WAS PERFORMED IN 2008 AND EXPEDIUM DI WAS APPLIED. THIS COMPLAINT INVOLVES TWENTY (20) DEVICES. THIS REPORT INVOLVES ONE (1) EXP DUAL-INNER SETSCREW. THIS IS REPORT 9 OF 20 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12373792 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD SUFFERED FROM THE ADJACENT DISEASE. ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED WITHOUT FURTHER ISSUE. THE PRIMARY PROCEDURE WAS PERFORMED IN 2008 AND EXPEDIUM DI WAS APPLIED. THIS COMPLAINT INVOLVES TWENTY (20) DEVICES. THIS REPORT INVOLVES ONE (1) EXP DI POLYAXL SCRW 6 X 40MM THIS IS REPORT 11 OF 20 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12373708 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD SUFFERED FROM THE ADJACENT DISEASE. ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED WITHOUT FURTHER ISSUE. THE PRIMARY PROCEDURE WAS PERFORMED IN 2008 AND EXPEDIUM DI WAS APPLIED. THIS COMPLAINT INVOLVES TWENTY (20) DEVICES. THIS REPORT INVOLVES ONE (1) EXP DI POLYAXL SCRW 6 X 40MM. THIS IS REPORT 13 OF 20 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12373707 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD SUFFERED FROM THE ADJACENT DISEASE. ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED WITHOUT FURTHER ISSUE. THE PRIMARY PROCEDURE WAS PERFORMED IN 2008 AND EXPEDIUM DI WAS APPLIED. THIS COMPLAINT INVOLVES TWENTY (20) DEVICES. THIS REPORT INVOLVES ONE (1) EXP DI POLYAXL SCRW 6 X 40MM. THIS IS REPORT 12 OF 20 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12373620 ↗
• InjuryJun 14, 2018Break; Break

  THE BROKEN SCREW WAS DISCOVERED DURING THE SPINE REVISION SURGERY ¿ THE REMOVAL OF N EXPEDIUM CONSTRUCT FROM LEVELS TH11 TO S1, IN WHICH THE BROKEN PIN WAS IMPLANTED IN LEVEL L1 (AND THE L2 VERTEBRA HAD A PRE-PRIMARY SURGERY FRACTURE ¿ THERE WERE NO SCREWS INSERTED IN VERTEBRAL BODY).

  Patient problems: Spinal Column Injury

  MAUDE report 7601279 ↗