NA 229.40Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982159571), received between Oct 25, 2022 and Oct 25, 2022 — 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. How this data works · Data updated Oct 13, 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.

• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON PLANNED TO REMOVE A LARGE FRAGMENT RECONSTRUCTION PLATE AND SCREWS FROM A PREVIOUS SHOULDER FUSION IN ORDER TO PERFORM AN IM NAILING OF A HUMERUS. THIS HARDWARE WAS SUCCESSFULLY REMOVED AND A MULTILOC HUMERAL NAIL WAS USED TO PASS THROUGH THE SHOULDER FUSION AND SUCCESSFULLY FIXATE THE FRACTURE. THERE WERE NO ALLEGATIONS AGAINST THE PLATE AND SCREW CONSTRUCT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 4.5MM RECONSTRUCTION PLATE 10 HOLES/157MM. THIS IS REPORT 1 OF 9 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15668466 ↗