NA 04.005.518SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982085870), received between Feb 23, 2023 and Mar 5, 2024 — 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 18, 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.

• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN TYPE OF INFECTION WAS CONFIRMED. THE INITIAL IMPLANTATION OCCURRED ON (B)(6) 2023. ON (B)(6) 2024, AN APPOINTMENT FOR A REMOVAL OF A TFNA IMPLANT WAS SCHEDULED. PATIENT OUTCOME WAS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 28MM F/IM NAIL-STER. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18841186 ↗
• InjuryFeb 23, 2023Adverse 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 INCISION & DRAINAGE AND HARDWARE REMOVAL AFTER AN MRI WITHOUT CONTRAST OF LEFT KNEE AND TIBIA/FIBULA ON (B)(6) 2021 SHOWED MARROW EDEMA WITHIN THE POSTERIOR ASPECT OF THE LEFT PROXIMAL TIBIA, CONCERNING FOR OSTEOMYELITIS. FLUID COLLECTION MEASURING APPROXIMATELY 2.8 X 1.5 X 2.8CM WAS NOTED ALONG THE ANTERIOR ASPECT OF THE PROXIMAL TIBIAL METAPHYSIS, ABUTTING THE MEDIALLY APPLIED SCREW. NOTABLE FOR EXTENSIVE SUBCUTANEOUS EDEMA WITH ASSOCIATED MYOSITIS. ALL HARDWARE WAS REMOVED PER ORTHOPEDICS. THIS REPORT INVOLVES ONE 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 28MM F/IM NAIL-STER. THIS PC IS RELATED TO THE FOLLOWING PCS: (B)(4) REPORTS PLATE BREAKAGE OF THE SAME PATIENT ON AN EARLIER DATE. (B)(4),(B)(4). REPORT INFECTION IN THE SAME PATIENT AT AN EARLIER DATE. THIS IS REPORT 9 OF 11 FOR (B)(4).

  Patient problems: Inflammation; Nonunion/Delayed-union Bone Fracture; Swelling/ Edema; Unspecified Infection

  MAUDE report 16426035 ↗