LCP 436.506Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982217974), received between Apr 18, 2022 and Apr 18, 2022 — classified as 1 injury.

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 18, 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.

• InjuryApr 18, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT A REVISION SURGERY DUE TO NON-UNION AND BROKEN HARDWARE. PATIENT PRESENTED WITH NON-UNION IN PRESENCE OF A BROKEN OLECRANON PLATE. BROKEN PLATE WAS IMPLANTED ¿OVER A YEAR AGO¿ AS PER SURGEON. SURGEON PERFORMED REVISION SURGERY TO REMOVE BROKEN PLATE, IMPLANT VIVIGEN BONE GRAFT, AND RE-PLATE USING A SYNTHES VARIABLE ANGLE OLECRANON PLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - BONE GRAFT HARVESTING (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN); UNK - SCREWS: LOCKING (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE(1) DEVICE 3.5 TI LCP OLECRANON PL 6 HOLES/RT/138. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 14135988 ↗

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,