EXPEDIUM 279726509Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034301525), received between Nov 16, 2020 and Sep 10, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (6 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE OPEN ALIGNMENT DEVICE AND OPEN ALIGNMENT SLEEVE WERE DAMAGED WHEN THE SURGEON ATTEMPTED TO ATTACH THE DEVICE TO THE SCREW HEAD. THERE WAS A PROBLEM WITH THE SCREW HEAD AND WHEN THE DOCTOR ATTEMPTED TO ATTACHED THE SLEEVE AND THE OPEN ALIGNMENT DEVICE THE TEETH THAT GRIPPED ON TO THE SCREW HEAD BROKE BECAUSE THE DOCTOR NEEDED TO APPLY SIGNIFICANT FORCE TO TRY GET IT ATTACHED TO THE SCREW HEAD. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT OUTCOME. THIS REPORT IS FOR AN OPEN ALIGNMENT SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182875 ↗
• MalfunctionJan 5, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR VIPER CFX CEMENTATION PROCEDURE. DURING THE SURGERY, IT WAS IMPOSSIBLE TO INJECT THE CONFIDENCE CEMENT WITHIN 2 SCREWS. THERE WAS NO FRAGMENT GENERATED. THE SURGERY WAS NOT COMPLETED SUCCESSFULLY. THERE WERE 15-MINUTES SURGICAL DELAY. NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) OPEN ALIGNMENT SLEEVE. THIS REPORT IS 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13170094 ↗
• MalfunctionNov 16, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, SIX (6) OPEN ALIGNMENT SLEEVES AND FOUR (4) OPEN ALIGNMENT DEVICES WERE UNABLE TO BE DECONTAMINATED DUE TO BLOCKAGES. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: FEN MINI CLEANING STYLET (PART#: 279726511, LOT#: UNKNOWN, QUANTITY: 1). ANTITORQUE WRENCH SELF RETAINING (PART#: 286745155, LOT#: UNKNOWN, QUANTITY: 2). FEN CANNULA PLUNGER (PART#: 279726402, LOT#: UNKNOWN, QUANTITY: 1). FEN CLEANING STYLET (PART#: 279726403, LOT#: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) OPEN ALIGNMENT SLEEVE. THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10848744 ↗
• MalfunctionNov 16, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, SIX (6) OPEN ALIGNMENT SLEEVES AND FOUR (4) OPEN ALIGNMENT DEVICES WERE UNABLE TO BE DECONTAMINATED DUE TO BLOCKAGES. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: FEN MINI CLEANING STYLET (PART# 279726511, LOT# UNKNOWN, QUANTITY 1); ANTI-TORQUE WRENCH SELF RETAINING (PART# 286745155, LOT# UNKNOWN, QUANTITY 2); FEN CANNULA PLUNGER (PART# 279726402, LOT# UNKNOWN, QUANTITY 1); FEN CLEANING STYLET (PART# 279726403, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) OPEN ALIGNMENT SLEEVE. THIS IS REPORT 5 OF 10 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10848578 ↗
• MalfunctionNov 16, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, SIX (6) OPEN ALIGNMENT SLEEVES AND FOUR (4) OPEN ALIGNMENT DEVICES WERE UNABLE TO BE DECONTAMINATED DUE TO BLOCKAGES. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: FEN MINI CLEANING STYLET (PART# 279726511, LOT# UNKNOWN, QUANTITY 1); ANTI-TORQUE WRENCH SELF RETAINING (PART# 286745155, LOT# UNKNOWN, QUANTITY 2); FEN CANNULA PLUNGER (PART# 279726402, LOT# UNKNOWN, QUANTITY 1); FEN CLEANING STYLET (PART# 279726403, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) OPEN ALIGNMENT SLEEVE. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10848484 ↗
• MalfunctionNov 16, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, SIX (6) OPEN ALIGNMENT SLEEVES AND FOUR (4) OPEN ALIGNMENT DEVICES WERE UNABLE TO BE DECONTAMINATED DUE TO BLOCKAGES. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: FEN MINI CLEANING STYLET (PART# 279726511, LOT# UNKNOWN, QUANTITY 1); ANTI-TORQUE WRENCH SELF RETAINING (PART# 286745155, LOT# UNKNOWN, QUANTITY 2); FEN CANNULA PLUNGER (PART# 279726402, LOT# UNKNOWN, QUANTITY 1); FEN CLEANING STYLET (PART# 279726403, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) OPEN ALIGNMENT SLEEVE. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10848403 ↗
• MalfunctionNov 16, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, SIX (6) OPEN ALIGNMENT SLEEVES AND FOUR (4) OPEN ALIGNMENT DEVICES WERE UNABLE TO BE DECONTAMINATED DUE TO BLOCKAGES. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: FEN MINI CLEANING STYLET (PART# 279726511, LOT# UNKNOWN, QUANTITY 1); ANTI-TORQUE WRENCH SELF RETAINING (PART# 286745155, LOT# UNKNOWN, QUANTITY 2); FEN CANNULA PLUNGER (PART# 279726402, LOT# UNKNOWN, QUANTITY 1); FEN CLEANING STYLET (PART# 279726403, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) OPEN ALIGNMENT SLEEVE. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10848347 ↗
• MalfunctionNov 16, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, SIX (6) OPEN ALIGNMENT SLEEVES AND FOUR (4) OPEN ALIGNMENT DEVICES WERE UNABLE TO BE DECONTAMINATED DUE TO BLOCKAGES. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: FEN MINI CLEANING STYLET (PART# 279726511, LOT# UNKNOWN, QUANTITY 1); ANTI-TORQUE WRENCH SELF RETAINING (PART# 286745155, LOT# UNKNOWN, QUANTITY 2); FEN CANNULA PLUNGER (PART# 279726402, LOT# UNKNOWN, QUANTITY 1); FEN CLEANING STYLET (PART# 279726403, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) OPEN ALIGNMENT SLEEVE. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10848250 ↗