INHANCE 6507-29-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295549680), received between Nov 9, 2023 and Oct 7, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT AFTER THE CASE THE TECH SHOWED SALES REP THAT THE MILL WAS STUCK INSIDE THE LARGE KICKSTAND GUIDE. SALES CONSULTANT WAS ABLE TO REMOVE IT AFTER THE PROCEDURE BUT WHILE CHECKING THE INSTRUMENTS TO MAKE SURE THEY WOULD STILL PREFORM CORRECTLY. UNFORTUNATELY THE MILL DIDN¿T SEEM TO FULLY SEAT INTO EITHER THE LARGE OR THE SMALL KICKSTAND GUIDE. ALL 3 ITEMS HAVE BEEN REMOVED FROM THE SET UNTIL REPLACED. THERE WAS NO DELAY TO THE SURGERY NOR WAS THERE ANY NEGATIVE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20390744 ↗
• MalfunctionNov 9, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT AFTER SURGERY, SALES REP TRIED TO TAKE PILOT ROD OUT OF THE LG KICKSTAND GUIDE HOWEVER THE TWO PIECES WOULD NOT BUDGE AND SEEMED TO BE STRIPPED/STUCK TOGETHER. THIS HAPPENED POST OP SO THERE WAS NO NEGATIVE EFFECT TO THE PATIENT, NOR WAS SURGERY TIME EXTENDED DUE TO THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18105877 ↗