Coupler II Main Assembly 5873Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842430104534), received between Oct 29, 2019 and Nov 12, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2025Break; Break

  KNOB ASSEMBLY OF THE SWIVEL ADAPTER BROKE DURING 180-DEGREE ROTATION PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535996 ↗
• InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MAYFIELD SLIPPED DURING PATIENT TRANSFER RESULTING IN A CUT ON THE PATIENT'S HEAD AND THE COUPLER II DEVICE WAS SOMEHOW INVOLVED IN THE INCIDENT.

  Patient problems: Laceration(s)

  MAUDE report 14778107 ↗
• MalfunctionMar 10, 2020Break; Break

  WHEN THE OPERATOR TURNED THE KNOB DURING SURGERY, IT BROKE HALFWAY. THEREFORE, THEY FIXED THE COUPLER BY CHUCKING THE THREAD WITH PLIERS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9811172 ↗
• MalfunctionOct 29, 2019Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  IT WAS REPORTED WHILE TRYING TO POSITION AN UNSTABLE CERVICAL SPINE, THE MAYFIELD OSI COUPLER ASSEMBLY ADAPTER FAILED TO TIGHTEN. PATIENT RECEIVED A MINOR LACERATION.

  Patient problems: Laceration(s)

  MAUDE report 9251713 ↗