LCP 441.284Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982221605), received between Mar 8, 2017 and Mar 8, 2017 — 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 (K033995); 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.

• InjuryMar 8, 2017Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A DISTAL HUMERUS FRACTURE WAS TREATED WITH A DISTAL HUMERAL PLATE AND A SECOND ONE ON THE DORSOLATERAL SIDE ON (B)(6) 2017. WHEN THE PATIENT WAS AT HOME ON (B)(6) 2017, THE PLATE BROKE AND ALSO ONE OF THE SCREWS, WITHOUT AN ACCIDENT (ACCORDING TO THE PATIENT). THE REVISION TOOK PLACE ON (B)(6) 2017. CONCOMITANT DEVICES: CORTEX SCREW (PART: 404.832, LOT: L104770, QUANTITY: 1). CORTEX SCREW (PART: 404.824, LOT: L129314, QUANTITY: 1). CORTEX SCREW (PART: 404.826, LOT: L233610, QUANTITY: 1) . LOCKING SCREW (PART: 413.040, LOT: L148519, QUANTITY: 1) . SCREWS (QUANTITY: 3). WIRE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 6387833 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033995. One submission often covers many models, so check the product and lot details in each record.

• Z-2278-2013 · Mar 8, 2013 · Terminated
  Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults