LCP 02.112.522Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982034595), received between Feb 24, 2018 and Nov 4, 2022 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2022 TO IMPLANT A MEDIAL DISTAL TIBIA PLATE. ON (B)(6) 2022, THE SURGEON PERFORMED A BONE GRAFTING OF A NONUNION OF THE DISTAL TIBIA FRACTURE. NO ALLEGATIONS WERE MADE AGAINST THE PLATE CONSTRUCT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/10H/RIGHT/187MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15729972 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A BONE GRAFTING WAS BEING PERFORMED ON A NON-UNION OF A DISTAL TIBIA. INITIAL IMPLANT DATE WAS (B)(6) 2021. NO HARDWARE WAS REMOVED AT THIS TIME. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/10H/RIGHT/187MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12964278 ↗
• InjuryFeb 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OFFICE VISIT (B)(6) 2017: ULCER PRESENT TO RLE (RIGHT LOWER EXTREMITY) AND PATIENT EXPERIENCING MILD PAIN, SWELLING AND ERYTHEMA. PATIENT SUSTAINED A LACERATION. HAS ENLARGED LYMPH NODES BUT NO PAIN ON WEIGHT BEARING. RIGHT INGUINAL LYMPHADENOPATHY PRESENT. RADIOGRAPHICALLY, TIBIA APPEARS TO BE PARTIALLY HEALED. FIBULA OSTEOTOMY IS HEALED. PATIENT REPORTED SHARP, INTERMITTENT, RADIATING PAIN IN HIS RIGHT LOWER LEG. PATIENT¿S VAC (RIGHT MEDIAL LEG) WAS CHANGED ON (B)(6) 2017.

  Patient problems: Unspecified Infection

  MAUDE report 7295041 ↗