NA 204.842Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982146397), received between Jul 9, 2018 and May 24, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Unintended Movement” (2 reports).

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.

• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A HARDWARE REMOVAL FOR THE FIBULA PLATE AND SCREWS AND 2 ASSOCIATED LAG SCREWS. THE SURGEON PERFORMED I&D AND NOTED THAT THE BONE IS MOSTLY HEALED AND APPEARED TO HAVE NO SIGN OF INFECTION. INITIALLY THE PATIENT HAD SURGERY TO REPAIR A FIBULA FRACTURE 4 OR 5 MONTHS AGO. AFTER 3 MONTHS POST OP THERE WAS A SIGN OF INFECTION AND TRIED TO TREAT WITH ANTIBIOTICS WITHOUT SUCCESS. THIS COMPLAINT INVOLVES ELEVEN (11) DEVICES. THIS REPORT IS FOR (1) 3.5MM CORTEX SCREW SELF-TAPPING 42MM. THIS REPORT IS 4 OF 14 (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 11873583 ↗
• InjuryJul 9, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF TWO STAINLESS SELF-TAPPING CORTEX SCREWS ON (B)(6) 2018. THE REMOVAL WAS DUE TO LOOSENING OF SCREWS. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. INITIAL DATE OF IMPLANT IS NOT KNOWN. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW 42MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7671226 ↗
• InjuryJul 9, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF TWO (2) STAINLESS SELF-TAPPING CORTEX SCREWS ON (B)(6) 2018. THE REMOVAL WAS DUE TO LOOSENING OF SCREWS. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. INITIAL DATE OF IMPLANT IS NOT KNOWN. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW 42MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7671192 ↗