NA 201.816Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982142986), received between Dec 13, 2018 and Dec 13, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, UPON TAKING THE RESTOCK FROM THE SIMS CABINET IN THE ACCOUNT TO RESTOCK THE SETS, AND AN UNOPENED BAGGIE WAS PULLED OUT FROM THE DRAWER. IT WAS NOTED THAT IT DID NOT CONTAIN THE RIGHT CORTEX SCREW OR THE STERILIZATION INSTRUCTIONS FOR AN IMPLANT. THE CORTEX SCREW WAS PURCHASED BY THE HOSPITAL AND WAS SHIPPED WITH AN EMPTY PACKAGE. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.0MM CORTEX SCREW SELF-TAPPING 16MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8161082 ↗