NA 02.200.050Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982047991), received between Dec 5, 2022 and Apr 27, 2023 — classified as 3 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 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.

• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SURGERY ON (B)(6) 2022 TO IMPLANT THE DEVICE. ON (B)(6) 2023, IT APPEARED THAT THE PATIENT HAD DEVELOPED A REACTION ISSUE WITH THE TITANIUM IN HIS LOWER LEG. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 8 OF 11 FOR (B)(4). THIS REPORT INVOLVES ONE (1) 3.5 SD CORTEX SCREW SELF-TAPPING 50.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16824868 ↗
• 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 50MM. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15914040 ↗
• 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 50MM. THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15914033 ↗