LPS 2987-72-035Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295159148), received between Aug 24, 2020 and Sep 30, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2024Break; Material Deformation; Naturally Worn; Break; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 2024, THE THREADS OF INSERTER/EXTRACTOR ARE STRIPPED. ALSO, THE BUTTON IS BROKEN. THE ISSUE DID NOT HAPPENED IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20333278 ↗
• MalfunctionAug 1, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE SURGEON COULD NOT THREAD COMPLETELY INTO IMPLANT OR TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15137898 ↗
• MalfunctionAug 24, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE IMPLANT THREADS ARE MESSED UP AND IT WON'T THREAD INTO THE IMPLANT. LOOKS CROSS THREADED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10441980 ↗