NA 04.226.634Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982123367), received between Jul 20, 2020 and Jul 20, 2020 — classified as 1 injury.

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.

• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE SURGEON REQUESTED THE LCP ELBOW AND 4.5MM HEADLESS COMPRESSION SETS AND SPECIFICALLY ASKED FOR THE THREE (3) HOLE PLATE TO BE IN THE SET FOR A PATIENT'S PROCEDURE SCHEDULED FOR (B)(6) 2020. UPON OPENING OF THE SET IN THE OPERATING ROOM, IT WAS DISCOVERED THE THIS THREE (3) HOLE RT PLATE WAS NOT IN THE SET. ADDITIONALLY, IN THE HEADLESS COMPRESSION SET, THERE WAS ONLY ONE OF EACH OF THE NEEDED SCREWS. A 20 MINUTE SURGICAL DELAY OCCURRED. THE SURGEON HAD TO MAKE ALTERNATIVE PLANS TO COMPLETE THE CASE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Injury

  MAUDE report 10294985 ↗