LCP 02.104.028SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982029157), received between Jul 30, 2021 and Oct 29, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 29, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A CASE USING AN EXTRA ARTICULAR DISTAL HUMERUS PLATE, ONE OF THE DISTAL LOCKING SCREWS WOULD NOT LOCK INTO THE OTHER PLATE. MULTIPLE SCREWS WERE USED AND WOULD NOT WORK. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556799 ↗
• InjuryJul 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT AN ORIF (OPEN REDUCTION INTERNAL FIXATION) DUE TO A NONUNION FRACTURE OF THE HUMERUS. THE ORIGINAL SURGERY PERFORMED APPROXIMATELY ONE (1) YEAR AGO FOR A GUNSHOT WOUND. THE HARDWARE WAS MOSTLY REMOVED EXCEPT FOR ONE (1) INTACT SCREW AND ONE BROKEN UNKNOWN 3.5 CORTEX SCREW TIP THAT WAS RETAINED. BONE GRAFTING WAS PERFORMED AND A NEW PLATE AND SCREW CONSTRUCT WAS APPLIED. THIS REPORT INVOLVES ONE (1) 3.5MM LCP EXTRA-ARTICLR DISTAL HUMERUS PL 8H/LT 194MM-STERIL. THIS IS REPORT 1 OF 11 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12256601 ↗