NA 214.870Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982154842), received between Jan 13, 2021 and Apr 12, 2023 — classified as 2 injuries.

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 2 most recent of 2 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 70MM. THIS IS REPORT 11 OF 14 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16724107 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REMOVAL AND REVISION OF HARDWARE DUE TO FALL. NO FRAGMENTS GENERATED. NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ELEVEN (11) DEVICES. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 70MM. THIS REPORT IS 3 OF 10 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11165110 ↗