LCP 422.220SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982215031), received between Jul 7, 2022 and May 30, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionMay 30, 2025Break; Defective Device; Break; Defective Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT ORIF SURGERY WITH THE PLATE IN QUESTION. BEFORE THE SURGERY, AN UNKNOWN DEFECT OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115884 ↗
• InjuryJul 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A SURGERY FOR A PROXIMAL TIBIA FRACTURE WITH TWO PLATES. REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2022. DURING THE REMOVAL SURGERY, ONE SCREW THAT FIXED ONE OF THE PLATES WAS DIFFICULT TO EXTRACT. THE SURGEON CUT THE SCREW HEAD WITH A CARBIDE DRILL, WHICH ALLOWED THE PLATE TO BE REMOVED. THE SHAFT OF THE SCREW THAT REMAINED IN THE BONE WAS EXTRACTED USING A HOLLOW REAMER. THIS REPORT IS FOR A TI LCP PROX LATERAL TIBIA PL 5 HOLES/140MM/RIGHT-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14943415 ↗