LCP 236.508Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982160775), received between Feb 28, 2017 and May 14, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, A 3.5MM LCP OLECRANON PLATE 8 HOLES/RIGHT/164MM WAS IMPLANTED ALONG WITH 8 SCREWS. ON (B)(6) 2018, A REVISION SURGERY WAS PERFORMED FOR NON-UNION AND FOR REMOVAL OF THE BROKEN PLATE. ONE BROKEN PLATE, SEVEN (7) 3.5MM LOCKING SCREWS AND ONE (1) 4.0MM UNKNOWN SCREW WERE REMOVED. ALL THE REMOVED SCREWS WERE INTACT. THE PROCEDURE WAS COMPLETED AND THERE WAS NO SURGICAL DELAY. NOTHING WAS IMPLANTED AFTER THE SURGERY, ONLY ANTIBIOTIC BEADS WERE PLACED INSIDE THE PATIENT. THE PATIENT WAS STABLE AFTER SURGERY. CONCOMITANT DEVICES REPORTED: 3.5MM LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QTY # 7), UNKNOWN 4.0MM SCREW (PART # UNKNOWN, LOT # UNKNOWN, QTY # 1). THIS REPORT IS FOR A 3.5MM LCP OLECRANON PLATE 8 HOLES/RIGHT/164MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 7511382 ↗
• InjuryFeb 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY IMPLANTED ON AN UNKNOWN DATE WITH ONE (1) 3.5MM LOCKING COMPRESSION PLATE (LCP) OLECRANON PLATE AND A UNKNOWN QUANTITY OF UNKNOWN SCREWS TO TREAT A OLECRANON FRACTURE. POST-OPERATIVELY, THE PATIENT PRESENTED WITH A LUMP OVER THE ORIGINAL FRACTURE SITE. ON (B)(6) 2017 PATIENT UNDERWENT REVISION/EXPLANT SURGERY. DURING THE PROCEDURE OSTEOMYELITIS WAS DISCOVERED IN THE BONE. DUE TO THE COMPLICATIONS OF THE PLATE AND SCREWS REMOVAL AN ADDITIONAL 60 MINUTES WAS ADDED TO OPERATING ROOM TIME. PATIENT IS REPORTED IN STABLE CONDITION AND SURGERY WAS COMPLETED SUCCESSFULLY BUT WITH SCREW FRAGMENTS BEING RETAINED. THIS REPORT ADDRESSES THE DEVELOPMENT OF OSTEOMYELITIS AND NEED FOR REVISION SURGERY. THE INTRAOPERATIVE EVENTS ARE ADDRESSED AND REPORTED IN RELATED COMPLAINT, (B)(4). THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 6364141 ↗

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,