NA 404.820Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982207326), received between Apr 23, 2021 and Dec 7, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 7, 2022Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE PRIMARY SURGERY WITH THE CORTEX SCREWS AND THE PLATE FOR THE DIAPHYSEAL FRACTURE OF THE HUMERUS. THE PATIENT WAS ALLOWED TO MOVE WITHOUT RESTRICTIONS FROM ABOUT SIX MONTHS AFTER THE SURGERY. THE PATIENT COMPLAINED OF PAIN. HOWEVER, X-RAY DID NOT SHOW ABNORMALITY. THE PHYSICIAN FOUND THAT THE CORTEX SCREW WAS BROKEN, AND BACK-OUT OF THE PLATE WAS CONFIRMED. IT IS UNKNOWN WHICH OF THE TWO SCREWS WAS BROKEN. ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED. THE PLATE WAS REPLACED, AND ILIAC WAS TRANSPLANTED. ACCORDING TO THE SURGEON, THE SCREW BREAKAGE MIGHT HAVE BEEN CAUSED BY UNRESTRICTED MOBILITY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.5MM TI CORTEX SCREW SELF-TAPPING 20MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 15933781 ↗
• InjuryAug 4, 2021Migration; Migration

  IT WAS REPORTED THAT PARTS WERE IMPLANTED IN 2017. LAST YEAR THE SCREWS STARTED BACKING OUT, AND THE PLATE AND SCREWS WERE REMOVED IN (B)(6) 2020. A NEW PLATE WAS NOT IMPLANTED AT THAT TIME DUE TO HOSPITAL RESTRICTIONS ON SURGERIES DUE TO COVID. A NEW PLATE WAS IMPLANTED IN (B)(6) 2021. PATIENT STATUS IS UNKNOWN. NO SURGICAL DELAY. THIS COMPLAINT INVOLVES (6) DEVICES. THIS REPORT IS FOR (1) 3.5MM TI CORTEX SCREW SELF-TAPPING 22MM. THIS REPORT IS 5 OF 6 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12277535 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, AN UNKNOWN HARDWARE REMOVAL PROCEDURE WAS PERFORMED FOR UNKNOWN REASON. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES THIRTEEN (13) DEVICES. THIS REPORT IS FOR (1) 3.5MM TI CORTEX SCREW SELF-TAPPING 20MM. THIS REPORT IS 5 OF 11 (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11717876 ↗