InCore Lapidus IC-LAP-3542Recalls & reported problems
Medartis Inc. · InCore Lapidus 3.5mm X 42mm Titanium Screw · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817701021032), received between Nov 1, 2019 and Nov 1, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 1, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
A PATIENT WAS IMPLANTED WITH THE INCORE LAPIDUS SYSTEM (LEFT POST, 3.5MM X 32MM SCREW, 3.5 X 42MM SCREW). AFTER SURGERY, THE 3.5MM X 42MM SCREW BROKE AT THE JUNCTION WITH THE POST. ALL PIECES OF THE INCORE LAPIDUS SYSTEM WERE REMOVED PER THE SURGICAL TECHNIQUE. THE SURGEON USED BONE FILLER AND A PLATE AFTER REMOVING INCORE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9268802 ↗
Other Screw, Fixation, Bone devices
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-375Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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