NA 212.221Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982152282), received between Jun 15, 2021 and Feb 22, 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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON OR ABOUT (B)(6) 2019, PATIENT SUFFERED FALL AND WAS IMPLANTED WITH 4.5 MM PROXIMAL TIBIAL PLATE AND SYNTHES SCREWS. ON OR ABOUT JANUARY 23 - 27, 2020, PATIENT DEVELOPED INFECTION AND WAS TREATED AND HOSPITALIZED. ON OR ABOUT (B)(6) 2020, X-RAY WAS TAKEN OF THE LEFT LOWER EXTREMITY WHICH REVEALED ACUTE FRACTURE IN THE 4.5 MM PROXIMAL TIBIAL PLATE. ON OR ABOUT JUNE 29, 2020 PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE DEFECTIVE FRACTURED 4.5 MM PROXIMAL TIBIAL PLATE AND OTHER ASSOCIATED SCREWS. THIS PC CREATED TO CAPTURE THE EVENT OF PATIENT'S INFECTION. THIS REPORT INVOLVES ONE 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 60MM. THIS IS REPORT 8 OF 10 FOR (B)(4). THIS PC IS RELATED TO THE FOLLOWING PCS: (B)(4) - REPORTS ADDITIONAL K-WIRES. (B)(4) - REPORTS IMPLANT BREAKAGE.

  Patient problems: Unspecified Infection

  MAUDE report 16417019 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON OR ABOUT (B)(6) 2019, PATIENT SUFFERED FALL AND WAS IMPLANTED WITH 4.5 MM PROXIMAL TIBIAL PLATE AND SYNTHES SCREWS. ON OR ABOUT (B)(6) 2020, PATIENT DEVELOPED INFECTION AND WAS TREATED AND HOSPITALIZED. ON OR ABOUT (B)(6) 2020, X-RAY WAS TAKEN OF THE LEFT LOWER EXTREMITY WHICH REVEALED ACUTE FRACTURE IN THE 4.5 MM PROXIMAL TIBIAL PLATE. ON OR ABOUT (B)(6) 2020 PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE DEFECTIVE FRACTURED 4.5 MM PROXIMAL TIBIAL PLATE AND OTHER ASSOCIATED SCREWS. THIS PC CREATED TO CAPTURE THE EVENT OF PATIENT'S INFECTION. THIS REPORT INVOLVES ONE UNK - GUIDE/COMPRESSION/K-WIRES. THIS IS REPORT 10 OF 10 FOR (B)(4). THIS PC IS RELATED TO THE FOLLOWING PCS: (B)(4) - REPORTS ADDITIONAL K-WIRES. (B)(4) - REPORTS IMPLANT BREAKAGE.

  Patient problems: Unspecified Infection

  MAUDE report 16417017 ↗
• InjuryJun 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT DUE TO INFECTION THE PATIENT UNDERWENT FOR A REVISION SURGERY TO REMOVE DEFECTIVE FRACTURED 4.5 MM PROXIMAL TIBIAL PLATE AND OTHER ASSOCIATED SCREWS. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES (7) DEVICES. THIS REPORT IS FOR (1) 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 60. THIS REPORT IS 5 OF 7 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection

  MAUDE report 12001918 ↗