SELF CENTERING 2055-39-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295084563), received between Aug 27, 2019 and Sep 10, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 16, 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, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721379 ↗
• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT THE TRIAL PIECE WAS BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753534 ↗
• 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 20439829 ↗
• MalfunctionOct 14, 2024Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information

  IT WAS REPORTED THAT THE HEAD TRIALS DID 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 20439088 ↗
• MalfunctionJun 3, 2020Break; Break

  IT WAS REPORTED THAT THE BIPOLAR SHELL 39MM IS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10114266 ↗
• MalfunctionAug 27, 2019Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  TRIALS ARE WORN. PATIENT STATUS / OUTCOME / CONSEQUENCES? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8934524 ↗
• MalfunctionAug 27, 2019Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  TRIALS ARE WORN. PATIENT STATUS/OUTCOME/CONSEQUENCES: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8934521 ↗
• MalfunctionAug 27, 2019Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  TRIALS ARE WORN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8934518 ↗