EXPEDIUM 179788530Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034081205), received between Jan 10, 2024 and Jan 12, 2024 — classified as 10 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT AN UNKNOWN SURGERY FOR ADOLESCENT IDIOPATHIC SCOLIOSIS WAS COMPLETED ON (B)(6) 2022. AFTER THE SURGERY, ON (B)(6) 2023, AN INFECTION WAS CONFIRMED ON CONCAVE SIDE. REVISION SURGERY OCCURRED ON (B)(6) 2023. DURING THE REVISION, THE SET SCREWS ON T2·3·4·5 ON THE LEFT WERE REMOVED. THE ROD WHERE THE SET SCREWS WERE REMOVED WERE CUT BY THE T-SAW. THE RODS WERE REMOVED. FOUR OF THE UNIPLANAR SCREWS (5.0 DIAMETER 30MM LONG) ON THE LEFT T2-T5 WERE REMOVED. THE AFFECTED AREA WAS WASHED. THE HOOK WAS PLACED ON T2 (WIDE BLADE/THROAT 10). SIDE-SIDE CONNECTOR INSTALLED AT THE UPPER END OF T5. TITANIUM ROD CONNECTION WAS PERFORMED BETWEEN T2 AND T5. THE WOUND WAS CLOSED.THIS REPORT IS FOR ONE EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 X 5.0 X 30MM FOR PC-(B)(4). THIS COMPLAINT IS LINKED TO PC-(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18504846 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT AN UNKNOWN SURGERY FOR ADOLESCENT IDIOPATHIC SCOLIOSIS WAS COMPLETED ON (B)(6) 2022.AFTER THE SURGERY, ON (B)(6) 2023, AN INFECTION WAS CONFIRMED ON CONCAVE SIDE. REVISION SURGERY OCCURRED ON (B)(6) 2023.DURING THE REVISION, THE SET SCREWS ON T2·3·4·5 ON THE LEFT WERE REMOVED. THE ROD WHERE THE SET SCREWS WERE REMOVED WERE CUT BY THE T-SAW. THE RODS WERE REMOVED. FOUR OF THE UNIPLANAR SCREWS (5.0 DIAMETER 30MM LONG) ON THE LEFT T2-T5 WERE REMOVED. THE AFFECTED AREA WAS WASHED. THE HOOK WAS PLACED ON T2 (WIDE BLADE/THROAT 10). SIDE-SIDE CONNECTOR INSTALLED AT THE UPPER END OF T5. TITANIUM ROD CONNECTION WAS PERFORMED BETWEEN T2 AND T5. THE WOUND WAS CLOSED.THIS REPORT IS FOR ONE EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 X 5.0 X 30MM FOR (B)(4).THIS COMPLAINT IS LINKED TO (B)(4), (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18504749 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS:IT WAS REPORTED THAT AN UNKNOWN SURGERY FOR ADOLESCENT IDIOPATHIC SCOLIOSIS WAS COMPLETED ON (B)(6), 2022.AFTER THE SURGERY, ON (B)(6), 2023, AN INFECTION WAS CONFIRMED ON CONCAVE SIDE. REVISION SURGERY OCCURRED ON (B)(6), 2023.DURING THE REVISION, THE SET SCREWS ON T2·3·4·5 ON THE LEFT WERE REMOVED. THE ROD WHERE THE SET SCREWS WERE REMOVED WERE CUT BY THE T-SAW. THE RODS WERE REMOVED. FOUR OF THE UNIPLANAR SCREWS (5.0 DIAMETER 30MM LONG) ON THE LEFT T2-T5 WERE REMOVED. THE AFFECTED AREA WAS WASHED. THE HOOK WAS PLACED ON T2 (WIDE BLADE/THROAT 10). SIDE-SIDE CONNECTOR INSTALLED AT THE UPPER END OF T5. TITANIUM ROD CONNECTION WAS PERFORMED BETWEEN T2 AND T5. THE WOUND WAS CLOSED.THIS REPORT IS FOR ONE EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 X 5.0 X 30MM FOR (B)(4).THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18504567 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT AN UNKNOWN SURGERY FOR ADOLESCENT IDIOPATHIC SCOLIOSIS WAS COMPLETED ON (B)(6) 2022. AFTER THE SURGERY, ON (B)(6) 2023, AN INFECTION WAS CONFIRMED ON CONCAVE SIDE. REVISION SURGERY OCCURRED ON (B)(6) 2023. DURING THE REVISION, THE SET SCREWS ON T2·3·4·5 ON THE LEFT WERE REMOVED. THE ROD WHERE THE SET SCREWS WERE REMOVED WERE CUT BY THE T-SAW. THE RODS WERE REMOVED. FOUR OF THE UNIPLANAR SCREWS (5.0 DIAMETER 30MM LONG) ON THE LEFT T2-T5 WERE REMOVED. THE AFFECTED AREA WAS WASHED. THE HOOK WAS PLACED ON T2 (WIDE BLADE/THROAT 10). SIDE-SIDE CONNECTOR INSTALLED AT THE UPPER END OF T5. TITANIUM ROD CONNECTION WAS PERFORMED BETWEEN T2 AND T5. THE WOUND WAS CLOSED. THIS REPORT IS FOR ONE EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 X 5.0 X 30MM FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18504524 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT AN UNKNOWN SURGERY FOR ADOLESCENT IDIOPATHIC SCOLIOSIS WAS COMPLETED ON (B)(6) 2022. AFTER THE SURGERY, ON (B)(6) 2023, AN INFECTION WAS CONFIRMED ON CONCAVE SIDE. REVISION SURGERY OCCURRED ON (B)(6) 2023. DURING THE REVISION, THE SET SCREWS ON T2·3·4·5 ON THE LEFT WERE REMOVED. THE ROD WHERE THE SET SCREWS WERE REMOVED WERE CUT BY THE T-SAW. THE RODS WERE REMOVED. FOUR OF THE UNIPLANAR SCREWS (5.0 DIAMETER 30MM LONG) ON THE LEFT T2-T5 WERE REMOVED. THE AFFECTED AREA WAS WASHED. THE HOOK WAS PLACED ON T2 (WIDE BLADE/THROAT 10). SIDE-SIDE CONNECTOR INSTALLED AT THE UPPER END OF T5. TITANIUM ROD CONNECTION WAS PERFORMED BETWEEN T2 AND T5. THE WOUND WAS CLOSED. THIS REPORT IS FOR ONE EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 X 5.0 X 30MM FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18504333 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT AN UNKNOWN SURGERY FOR ADOLESCENT IDIOPATHIC SCOLIOSIS WAS COMPLETED ON (B)(6) 2022.AFTER THE SURGERY, ON (B)(6), 2023, AN INFECTION WAS CONFIRMED ON CONCAVE SIDE. REVISION SURGERY OCCURRED ON (B)(6), 2023. DURING THE REVISION, THE SET SCREWS ON T2·3·4·5 ON THE LEFT WERE REMOVED. THE ROD WHERE THE SET SCREWS WERE REMOVED WERE CUT BY THE T-SAW. THE RODS WERE REMOVED. FOUR OF THE UNIPLANAR SCREWS (5.0 DIAMETER 30MM LONG) ON THE LEFT T2-T5 WERE REMOVED. THE AFFECTED AREA WAS WASHED. THE HOOK WAS PLACED ON T2 (WIDE BLADE/THROAT 10). SIDE-SIDE CONNECTOR INSTALLED AT THE UPPER END OF T5. TITANIUM ROD CONNECTION WAS PERFORMED BETWEEN T2 AND T5. THE WOUND WAS CLOSED. THIS REPORT IS FOR ONE EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 X 5.0 X 30MM FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18504069 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT AN UNKNOWN SURGERY FOR ADOLESCENT IDIOPATHIC SCOLIOSIS WAS COMPLETED ON (B)(6) 2022. AFTER THE SURGERY, ON (B)(6) 2023, AN INFECTION WAS CONFIRMED ON CONCAVE SIDE. REVISION SURGERY OCCURRED ON (B)(6) 2023. DURING THE REVISION, THE SET SCREWS ON T2·3·4·5 ON THE LEFT WERE REMOVED. THE ROD WHERE THE SET SCREWS WERE REMOVED WERE CUT BY THE T-SAW. THE RODS WERE REMOVED. FOUR OF THE UNIPLANAR SCREWS (5.0 DIAMETER 30MM LONG) ON THE LEFT T2-T5 WERE REMOVED. THE AFFECTED AREA WAS WASHED. THE HOOK WAS PLACED ON T2 (WIDE BLADE/THROAT 10). SIDE-SIDE CONNECTOR INSTALLED AT THE UPPER END OF T5. TITANIUM ROD CONNECTION WAS PERFORMED BETWEEN T2 AND T5. THE WOUND WAS CLOSED. THIS REPORT IS FOR ONE EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 X 5.0 X 30MM FOR (B)(4) THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18503803 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT AN UNKNOWN SURGERY FOR ADOLESCENT IDIOPATHIC SCOLIOSIS WAS COMPLETED ON (B)(6) 2022. AFTER THE SURGERY, ON (B)(6) 2023, AN INFECTION WAS CONFIRMED ON CONCAVE SIDE. REVISION SURGERY OCCURRED ON (B)(6) 2023. DURING THE REVISION, THE SET SCREWS ON T2·3·4·5 ON THE LEFT WERE REMOVED. THE ROD WHERE THE SET SCREWS WERE REMOVED WERE CUT BY THE T-SAW. THE RODS WERE REMOVED. FOUR OF THE UNIPLANAR SCREWS (5.0 DIAMETER 30MM LONG) ON THE LEFT T2-T5 WERE REMOVED. THE AFFECTED AREA WAS WASHED. THE HOOK WAS PLACED ON T2 (WIDE BLADE/THROAT 10). SIDE-SIDE CONNECTOR INSTALLED AT THE UPPER END OF T5. TITANIUM ROD CONNECTION WAS PERFORMED BETWEEN T2 AND T5. THE WOUND WAS CLOSED. THIS REPORT IS FOR ONE EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 X 5.0 X 30MM FOR PC-001506646 THIS COMPLAINT IS LINKED TO (B)(4), (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18503730 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT AN UNKNOWN SURGERY FOR ADOLESCENT IDIOPATHIC SCOLIOSIS WAS COMPLETED ON (B)(6) 2022. AFTER THE SURGERY, ON (B)(6) 2023, AN INFECTION WAS CONFIRMED ON CONCAVE SIDE. REVISION SURGERY OCCURRED ON (B)(6) 2023. DURING THE REVISION, THE SET SCREWS ON T2·3·4·5 ON THE LEFT WERE REMOVED. THE ROD WHERE THE SET SCREWS WERE REMOVED WERE CUT BY THE T-SAW. THE RODS WERE REMOVED. FOUR OF THE UNIPLANAR SCREWS (5.0 DIAMETER 30MM LONG) ON THE LEFT T2-T5 WERE REMOVED. THE AFFECTED AREA WAS WASHED. THE HOOK WAS PLACED ON T2 (WIDE BLADE/THROAT 10). SIDE-SIDE CONNECTOR INSTALLED AT THE UPPER END OF T5. TITANIUM ROD CONNECTION WAS PERFORMED BETWEEN T2 AND T5. THE WOUND WAS CLOSED. THIS REPORT IS FOR ONE EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 X 5.0 X 30MM FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18502871 ↗
• 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 30MM. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18484922 ↗