LCP 441.457Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982222084), received between Jan 20, 2023 and Jan 20, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (1 report).

1 other recall cover devices cleared under the same FDA submission (K000684); they may or may not involve this specific model.

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

• InjuryJan 20, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(4) 2022, THE PATIENT UNDERWENT ORIF FOR TIBIAL DIAPHYSEAL FRACTURE WITH THE PRODUCT IN QUESTION AND AUTOLOGOUS BONE GRAFTING WAS PERFORMED ON THE PATIENT'S BONE DEFECTS. THE PATIENT WAS REHABILITATED WITH PARTIAL LOAD, BUT ON (B)(6) 2022, THE PATIENT FELL AND THE PLATE WAS BENT AND DAMAGED. ON (B)(6) 2022, REOPERATION WAS PERFORMED TO REMOVE THE PLATE AND FIX WITH TNA. THE SURGEON COMMENTED THAT THE PRODUCT DAMAGE WAS UNAVOIDABLE BECAUSE OF THE PATIENT'S FALL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.5MM TI LCP(TM) ANTEROLATERAL DISTAL TIBIA PL 21 HOLES/LEFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Fall

  MAUDE report 16216265 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,