NA 202.845Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982144898), received between Nov 7, 2021 and Jan 29, 2024 — classified as 3 injuries, 2 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FACILITY RECEIVED AN ORDER. ONE ITEM WAS RECEIVED THAT WAS CORRECT; THE SECOND ONE WAS ONLY THE PACKAGE WITH NO ITEM INSIDE. THIS REPORT IS FOR A 2.7MM CORTEX SCREW SELF-TAPPING 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18597600 ↗
• InjuryOct 18, 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 PERFORMED A REMOVAL OF HARDWARE DUE TO PAIN AND IRRITATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.7MM CORTEX SCREW SELF-TAPPING 45MM. THIS IS REPORT 9 OF 14 FOR (B)(4).

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 15628467 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER THAT POSTOPERATIVELY TO AN UNKNOWN SURGERY ON AN UNKNOWN DATE, A PATIENT UNDERWENT A DEVICE REMOVAL IN THE LEFT ANKLE ON (B)(6) 2022 DUE TO PAIN. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL . NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR (1) 2.7MM CORTEX SCREW SELF-TAPPING 45MM DEVICE. THIS COMPLAINT INVOLVES (3) DEVICES.

  Patient problems: Pain

  MAUDE report 14147011 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER THAT POSTOPERATIVELY TO AN UNKNOWN SURGERY ON AN UNKNOWN DATE, A PATIENT UNDERWENT A DEVICE REMOVAL IN THE LEFT ANKLE ON (B)(6) 2022 DUE TO PAIN. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL . NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 2.7MM CORTEX SCREW SELF-TAPPING 45MM DEVICE. THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: Pain

  MAUDE report 14146797 ↗
• MalfunctionNov 7, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE FOR AN OPEN REDUCTION INTERNAL FIXATION OF PROXIMAL FEMUR THE SCREW HEADS WAS BROKEN. PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT OUTCOME WAS AS PLANNED. THIS REPORT IS FOR ONE (1) 2.7MM CORTEX SCREW SELF-TAPPING 45MM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12758823 ↗