InCore Lapidus IC-LAP-0101LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817701021162), received between Jul 20, 2018 and Jul 20, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Jam” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2018Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A LAPIDUS PROCEDURE OF THE 1ST TMT JOINT, A DRILL BIT SEIZED IN THE TARGETING GUIDE INSTRUMENT. THE TARGETING GUIDE WAS REMOVED AND DURING THE REMOVAL THE SURGEON STATED THAT THE MEDIAL CUNEIFORM FRACTURED DISTALLY INTO THE FUSION SITE. THE REMOVAL OF THE INSTRUMENT AND THE FRACTURED CUNEIFORM CAUSED A 30-MINUTE SURGICAL DELAY. THE FRACTURE WAS PLATED AS WELL AS THE LAPIDUS PROCEDURE COMPLETED WITH A TYPICAL PLATE AND SCREW APPROACH WITHOUT ANY SUBSEQUENT ISSUE.

  Patient problems: Bone Fracture(s)

  MAUDE report 7706540 ↗