LCP 236.502Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982160652), received between Sep 6, 2019 and Sep 6, 2019 — classified as 1 injury.

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.

• InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN (B)(6) 2018 THE PATIENT UNDERWENT A REMOVAL SURGERY TO REMOVE THE SYNTHES OLECRANON PLATE DUE TO PAIN AND SYMPTOMATIC HARDWARE. ON (B)(6) 2016, THE PATIENT WAS ASSEMBLING A PARADE FLOAT WHERE SHE WAS KNOCKED OFF BY AN OBJECT AND FELL 5 FEET TO THE GROUND. SHE FELL ON OUTSTRETCHED HANDS AND THEN ONTO HER FACE. SHE REPORTS SIGNIFICANT AMOUNT OF PAIN IN BILATERAL UPPER EXTREMITIES AND LEFT SIDE OF FACE. SHE SUFFERED AN ELBOW FRACTURE THAT REQUIRED SURGERY AND THE PLACEMENT OF A SYNTHES RADIAL HEAD PROSTHESIS SYSTEM IN HER LEFT ELBOW AND SYNTHES OLECRANON LOCKING PLATE AND SCREWS IN HER RIGHT ELBOW. ON (B)(6) 2017, PATIENT'S MAIN COMPLAINT WAS DECREASED LEFT SUPINATION AND ALSO COMPLAINS OF OCCASIONAL POPPING OR MILD CREPITUS ABOUT HER LEFT ELBOW AND FOREARM. THERE WAS ALSO A SUPERFICIAL TENDER NODULE ON HER LEFT MEDIAL ELBOW AND COMPLAINED OF MEDIAL-SIDED ELBOW PAIN. IN REGARDS TO HER RIGHT ELBOW, SHE COMPLAINED OF GLOBAL PAIN AND THE INABILITY TO COMPLETELY EXTEND HER ELBOW. SHE ALSO HAS A PROMINENCE OF THE OLECRANON PLATE. ON (B)(6) 2018, THE PATIENT UNDERWENT REMOVAL HARDWARE. MULTIPLE STAB WOUNDS WERE MADE ALONG THE COURSE OF THE OLECRANON PLATE AND THE

  Patient problems: Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8972535 ↗

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,