LCP 312.947Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982188151), received between Feb 19, 2020 and Apr 6, 2021 — classified as 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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 6, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE DISTAL FEMORAL FRACTURE. THE GUIDING BLOCK WAS DEFORMED PARTIALLY, AND THE SURGEON COULD NOT INSERT THE DRILL GUIDE INTO ONE OF THE HOLES OF THE GUIDING BLOCK. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT CONDITION WAS STABLE. CONCOMITANT DEVICE REPORTED: UNK - GUIDES/SLEEVES/AIMING: GUIDE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY:1. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) GUIDE BLOCK FOR LCP(TM) DISTAL FEMUR PLATES-LEFT. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11620619 ↗
• MalfunctionFeb 19, 2020Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FEMORAL MALLEOLAR FRACTURE WITH THE GUIDING BLOCK IN QUESTION. DURING THE SURGERY, AFTER THE SURGEON FIXED THE GUIDING BLOCK TO A PLATE, HE COULD NOT INSERT A DRILL GUIDE TO ONE HOLE. THE SURGEON USED A DRILL GUIDE WITHOUT THE GUIDING BLOCK REGARDING THE AFFECTED HOLE. AFTER THE SURGERY, THE HOSPITAL FOUND THAT THEY COULD NOT INSERT THE DRILL GUIDE TO A HOLE OF THE GUIDING BLOCK BECAUSE IT WAS DEFORMED. IT IS UNKNOWN WHEN THE HOLE WAS DEFORMED. PATIENT OUTCOME IS STABLE. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNK - PLATE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN); UNK - GUIDES/SLEEVES/AIMING: GUIDE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9728821 ↗