NA 214.868Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982154835), received between Apr 12, 2023 and Apr 12, 2023 — 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 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.

• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2020, AN X-RAY OF FEMUR REPORT AND REVEALED A CLOSED COMMINUTED SUPRACONDYLAR FRACTURE OF LEFT FEMUR WITH NONUNION. DOI: (B)(6) 2019; DOE: (B)(6) 2020; LEFT FEMUR. THIS REPORT IS FOR A 4.5MM CORTEX SCREW SELF-TAPPING 68MM. THIS IS REPORT 10 OF 14 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16724074 ↗