NA 02.200.014Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982047809), received between Dec 5, 2022 and Dec 5, 2022 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM DENMARK REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT EXPERIENCED AN ALLERGIC REACTION CAUSED BY AN IMPLANT IN THE ANKLE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 14MM. THIS IS REPORT 8 OF 10 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15914022 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM DENMARK REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT EXPERIENCED AN ALLERGIC REACTION CAUSED BY AN IMPLANT IN THE ANKLE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 14MM. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15913973 ↗