LCP 02.104.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982029041), received between Apr 2, 2019 and Nov 14, 2022 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionNov 14, 2022Material Deformation; Material Deformation

  IT WAS REPORTED ON UNKNOWN EVEN DATE THAT POST OP INSPECTION OCCURRED GRAPHIC CASE HAD WHITE SANDY DUE TO VOLUME OF USAGE AND PEELING OF GRAPHIC CASE. SHORT POWER SHAFTS WERE WARPED DUE TO USAGE, AND KEPT STRIPPING SCREWS. CONNECTING ELEMENT THREADS WERE STRIPPED AFTER USAGE. PLATES WERE BENT AFTER WASH FROM CSPD. NO PATIENT AND PROCEDURE OUTCOME AND NO SURGICAL DELAY REPORTED BECAUSE IT IS A POST OF EVENT. THIS REPORT IS FOR ONE (1)3.5 LCP X-ARTC DSTL HUM PL 10H/RT 230 LG. THIS IS REPORT 3 OF 6 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15792082 ↗
• MalfunctionNov 14, 2022Material Deformation; Material Deformation

  IT WAS REPORTED ON UNKNOWN EVEN DATE THAT POST OP INSPECTION OCCURRED GRAPHIC CASE HAD WHITE SANDY DUE TO VOLUME OF USAGE AND PEELING OF GRAPHIC CASE. SHORT POWER SHAFTS WERE WARPED DUE TO USAGE, AND KEPT STRIPPING SCREWS. CONNECTING ELEMENT THREADS WERE STRIPPED AFTER USAGE. PLATES WERE BENT AFTER WASH FROM CSPD. NO PATIENT AND PROCEDURE OUTCOME AND NO SURGICAL DELAY REPORTED BECAUSE IT IS A POST OF EVENT. THIS REPORT IS FOR ONE (1)3.5 LCP X-ARTC DSTL HUM PL 10H/RT 230 LG. THIS IS REPORT 6 OF 6 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15792014 ↗
• InjuryApr 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN UNKNOWN HARDWARE REMOVAL PROCEDURE DUE TO NONUNION. THE PATIENT HAD A DISTAL HUMERUS FRACTURE ON UNKNOWN DATE. FOUR (4) 3.5 CORTEX SCREWS, FOUR (4) 3.5 LOCKING SCREWS, AND TWO (2) 2.7 VA LOCKING SCREWS WERE REMOVED FROM THE LOCKING COMPRESSION PLATE (LCP) EXTRA-ARTICULAR DISTAL HUMERUS PLATE AND VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) MEDIAL DISTAL HUMERUS PLATE. THE SURGEON DECIDED TO CONVERT IT INTO TOTAL ELBOW PROSTHESIS. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR AN LCP EXTRA-ARTICULAR DISTAL HUMERUS PLATE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8473404 ↗