NA 2531-09-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295129097), received between Mar 30, 2020 and Feb 8, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Crack” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2023Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn

  IT WAS REPORTED THAT THE TRIAL HEADS WERE WORN TO THE POINT THE PLASTIC WAS FLAKING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16325603 ↗
• MalfunctionFeb 8, 2023Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn

  IT WAS REPORTED THAT THE TRIAL HEADS WERE WORN TO THE POINT THE PLASTIC WAS FLAKING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16325376 ↗
• MalfunctionJan 29, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TRIAL HAS FOUR AREAS ON IT THAT SEEM TO HAVE BEEN MELTED. IT WAS NOT USED IN PATIENT. IT WAS NOTICED BY REP AT END OF CASE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261906 ↗
• MalfunctionOct 18, 2020Crack; Material Twisted/Bent; Crack; Material Twisted/Bent

  IT WAS REPORTED THAT THE HEADS ARE IN A BAD SHAPE. PLASTIC IS CUT INTO FROM RETRACTS AND INSTRUMENTS. NO SURGICAL DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10694942 ↗
• MalfunctionOct 18, 2020Crack; Material Twisted/Bent; Crack; Material Twisted/Bent

  IT WAS REPORTED THAT THE HEADS ARE IN A BAD SHAPE. PLASTIC IS CUT INTO FROM RETRACTS AND INSTRUMENTS. NO SURGICAL DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10694940 ↗
• MalfunctionOct 18, 2020Crack; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Crack; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEADS ARE IN A BAD SHAPE. PLASTIC IS CUT INTO FROM RETRACTS AND INSTRUMENTS. NO SURGICAL DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10694937 ↗
• MalfunctionOct 18, 2020Crack; Material Twisted/Bent; Crack; Material Twisted/Bent

  IT WAS REPORTED THAT THE HEADS ARE IN A BAD SHAPE. PLASTIC IS CUT INTO FROM RETRACTS AND INSTRUMENTS. NO SURGICAL DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10694931 ↗
• MalfunctionMar 30, 2020Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE 32 + 40MM HEAD TRIALS NEED REPLACED DUE TO SCRATCHES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9901032 ↗
• MalfunctionMar 30, 2020Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE 32 + 40MM HEAD TRIALS NEED REPLACED DUE TO SCRATCHES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9901003 ↗