EXPEDIUM 179788535Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034081212), received between Jan 10, 2024 and Apr 1, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2024Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED DURING AN UNKNOWN SURGERY FOR AIS PERFORMED ON AN UNKNOWN DATE, THE SET SCREW IN QUESTION CROSS-THREADED DURING FINAL FASTENING. THE SET SCREWS WERE CHANGED SEVERAL TIMES, BUT IT DID NOT SOLVE. THE SURGEON TIGHTENED IT MANUALLY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS WAS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) EXP TI UNI SCW 5MMX35MM THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19013386 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, AN UNKNOWN SURGERY WAS PERFORMED FOR ADOLESCENT IDIOPATHIC SCOLIOSIS. AFTER THE SURGERY ON (B)(6) 2023, AN INFECTION WAS CONFIRMED ON THE CONCAVE SIDE. A REVISION PROCEDURE WAS SCHEDULED FOR AND PERFORMED ON (B)(6) 2023. THE SET SCREWS ON T2, 3, 4, AND 5 ON THE LEFT WERE REMOVED. THE ROD WHERE THE SET SCREWS WERE REMOVED WERE CUT AND REMOVED. FOUR UNIPLANAR SCREWS WERE REMOVED ON THE LEFT OF T2-T5. THE AFFECTED AREA WAS WASHED, AND A HOOK WAS PLACED ON T2. A SIDE-SIDE CONNECTOR WAS INSTALLED AT THE UPPER END OF T5, AND TITANIUM ROD CONNECTION WAS PERFORMED BETWEEN T2 AND T5. THE WOUND WAS CLOSED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 X 5.0 X 35MM. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18494525 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, AN UNKNOWN SURGERY WAS PERFORMED FOR ADOLESCENT IDIOPATHIC SCOLIOSIS. AFTER THE SURGERY ON 18-DECEMBER-2023, AN INFECTION WAS CONFIRMED ON THE CONCAVE SIDE. A REVISION PROCEDURE WAS SCHEDULED FOR AND PERFORMED ON (B)(6) 2023. THE SET SCREWS ON T2, 3, 4, AND 5 ON THE LEFT WERE REMOVED. THE ROD WHERE THE SET SCREWS WERE REMOVED WERE CUT AND REMOVED. FOUR UNIPLANAR SCREWS WERE REMOVED ON THE LEFT OF T2-T5. THE AFFECTED AREA WAS WASHED, AND A HOOK WAS PLACED ON T2. A SIDE-SIDE CONNECTOR WAS INSTALLED AT THE UPPER END OF T5, AND TITANIUM ROD CONNECTION WAS PERFORMED BETWEEN T2 AND T5. THE WOUND WAS CLOSED. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 X 5.0 X 35MM. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18484971 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, AN UNKNOWN SURGERY WAS PERFORMED FOR ADOLESCENT IDIOPATHIC SCOLIOSIS. AFTER THE SURGERY ON (B)(6) 2023, AN INFECTION WAS CONFIRMED ON THE CONCAVE SIDE. A REVISION PROCEDURE WAS SCHEDULED FOR AND PERFORMED ON (B)(6) 2023. THE SET SCREWS ON T2, 3, 4, AND 5 ON THE LEFT WERE REMOVED. THE ROD WHERE THE SET SCREWS WERE REMOVED WERE CUT AND REMOVED. FOUR UNIPLANAR SCREWS WERE REMOVED ON THE LEFT OF T2-T5. THE AFFECTED AREA WAS WASHED, AND A HOOK WAS PLACED ON T2. A SIDE-SIDE CONNECTOR WAS INSTALLED AT THE UPPER END OF T5, AND TITANIUM ROD CONNECTION WAS PERFORMED BETWEEN T2 AND T5. THE WOUND WAS CLOSED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 X 5.0 X 35MM. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18484969 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, AN UNKNOWN SURGERY WAS PERFORMED FOR ADOLESCENT IDIOPATHIC SCOLIOSIS. AFTER THE SURGERY ON (B)(6) 2023, AN INFECTION WAS CONFIRMED ON THE CONCAVE SIDE. A REVISION PROCEDURE WAS SCHEDULED FOR AND PERFORMED ON (B)(6) 2023. THE SET SCREWS ON T2, 3, 4, AND 5 ON THE LEFT WERE REMOVED. THE ROD WHERE THE SET SCREWS WERE REMOVED WERE CUT AND REMOVED. FOUR UNIPLANAR SCREWS WERE REMOVED ON THE LEFT OF T2-T5. THE AFFECTED AREA WAS WASHED, AND A HOOK WAS PLACED ON T2. A SIDE-SIDE CONNECTOR WAS INSTALLED AT THE UPPER END OF T5, AND TITANIUM ROD CONNECTION WAS PERFORMED BETWEEN T2 AND T5. THE WOUND WAS CLOSED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 X 5.0 X 35MM. THIS IS REPORT 5 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18484940 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, AN UNKNOWN SURGERY WAS PERFORMED FOR ADOLESCENT IDIOPATHIC SCOLIOSIS. AFTER THE SURGERY ON (B)(6) 2023, AN INFECTION WAS CONFIRMED ON THE CONCAVE SIDE. A REVISION PROCEDURE WAS SCHEDULED FOR AND PERFORMED ON (B)(6) 2023. THE SET SCREWS ON T2, 3, 4, AND 5 ON THE LEFT WERE REMOVED. THE ROD WHERE THE SET SCREWS WERE REMOVED WERE CUT AND REMOVED. FOUR UNIPLANAR SCREWS WERE REMOVED ON THE LEFT OF T2-T5. THE AFFECTED AREA WAS WASHED, AND A HOOK WAS PLACED ON T2. A SIDE-SIDE CONNECTOR WAS INSTALLED AT THE UPPER END OF T5, AND TITANIUM ROD CONNECTION WAS PERFORMED BETWEEN T2 AND T5. THE WOUND WAS CLOSED. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 X 5.0 X 35MM. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18484930 ↗