NA 02.206.222Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982051004), received between Jan 16, 2018 and Mar 24, 2021 — classified as 2 injuries, 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 18, 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.

• MalfunctionMar 24, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING RECEIPT OF PRODUCT FOR REPLENISHMENT INVENTORY, THE 3.5MM CORTEX SCREWS SELF-TAPPING LOW-PROFILE T15 STARDRIVE RECESS WAS NOT THE PART IN THE PACKAGE. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT IS FOR A 3.5 CORTEX SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11560753 ↗
• InjuryJan 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF A 1 PLATE, 4 CORTEX SCREW. 4 VARIABLE ANGLE LOCKING COMPRESSION SCREW AND 1 METAPHYSEAL SCREW ON (B)(6) 2017 DUE TO RIGHT TIBIAL INFECTION. THE PLATE AND SCREWS WERE ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. THE DEVICES WERE REMOVED INTACT AND AN ANTIBIOTIC NAIL WAS IMPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED AS FINE. THE PATIENT MAY BE SCHEDULED FOR ADDITIONAL SURGERIES AS PART OF A STAGED RE-IMPLANTATION. THIS COMPLAINT IS FOR TEN (10) DEVICES. (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7194167 ↗
• InjuryJan 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF A 1 PLATE, 4 CORTEX SCREW. 4 VARIABLE ANGLE LOCKING COMPRESSION SCREW AND 1 METAPHYSEAL SCREW ON (B)(6) 2017 DUE TO RIGHT TIBIAL INFECTION. THE PLATE AND SCREWS WERE ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. THE DEVICES WERE REMOVED INTACT AND AN ANTIBIOTIC NAIL WAS IMPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED AS FINE. THE PATIENT MAY BE SCHEDULED FOR ADDITIONAL SURGERIES AS PART OF A STAGED RE-IMPLANTATION. THIS COMPLAINT IS FOR TEN (10) DEVICES. (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7194035 ↗