SELF CENTERING 2055-57-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295084747), received between May 19, 2022 and Jan 27, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE MOD ENDO BIPOLAR HEAD TRIALS LOST POST OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24186997 ↗
• MalfunctionOct 14, 2024Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information

  IT WAS REPORTED THAT HEAD TRIALS DID NOT FIT ON TRIAL STICK AND SIZES ARE NOT VISIBLE. THESE WERE FOUND AFTER THE CASE SO THERE WERE NO ADVERSE CONSEQUENCES AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441821 ↗
• MalfunctionOct 14, 2024Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information

  IT WAS REPORTED THAT THE HEAD TRIALS DO NOT FIT ONTO TRIAL STICK. THE SIZES ARE NOT VISIBLE ON THE HEAD TRIALS. THESE WERE FOUND AFTER THE CASE SO THERE WERE NO ADVERSE CONSEQUENCES AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439293 ↗
• MalfunctionSep 25, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE ROD ENDO HEAD TRIALS WERE GETTING OLD AND DO NOT FIT ON THE TRIAL STICK. THESE WERE FOUND AFTER THE CASE SO THERE WAS NO SURGICAL DELAY AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302606 ↗
• MalfunctionApr 29, 2024Naturally Worn; Naturally Worn

  NO HARM AND NO DELAY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19200616 ↗
• MalfunctionApr 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PIECES OF THE INSTRUMENTS WERE JUST WORN OUT AND NEED REPLACING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183558 ↗
• MalfunctionMay 19, 2022Naturally Worn; Illegible Information; Naturally Worn; Illegible Information

  IT WAS REPORTED THAT THE SIZING INFORMATION WORN OFF TRIALS DUE TO MULTIPLE AUTOCLAVING/USAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14433802 ↗