NA 02.127.126Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982043177), received between Jan 28, 2022 and Jan 28, 2022 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REMOVAL OF VARIABLE ANGLE MEDIAL TIBIA PLATE AND CORRESPONDING SCREWS DUE TO NONUNION. THE MEDIAL PLATE WAS ORIGINALLY PUT ON THE LATERAL SIDE OF THE PATIENTS TIBIA. SURGEON REMOVED ALL HARDWARE, CREATED AN OSTEOTOMY, THEN PUT IN A ZIMMER HINDFOOT NAIL AS WELL AS SYNTHES VA PROXIMAL TIBIA PLATE. PATIENT CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR ONE (1) 3.5 VA LCKNG SCR SLF-TPNG/SD/26. THIS IS REPORT 14 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 13388695 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REMOVAL OF VARIABLE ANGLE MEDIAL TIBIA PLATE AND CORRESPONDING SCREWS DUE TO NONUNION. THE MEDIAL PLATE WAS ORIGINALLY PUT ON THE LATERAL SIDE OF THE PATIENTS TIBIA. SURGEON REMOVED ALL HARDWARE, CREATED AN OSTEOTOMY, THEN PUT IN A ZIMMER HINDFOOT NAIL AS WELL AS SYNTHES VA PROXIMAL TIBIA PLATE. PATIENT CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR ONE (1) 3.5 VA LCKNG SCR SLF-TPNG/SD/26. THIS IS REPORT 12 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 13388684 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REMOVAL OF VARIABLE ANGLE MEDIAL TIBIA PLATE AND CORRESPONDING SCREWS DUE TO NONUNION. THE MEDIAL PLATE WAS ORIGINALLY PUT ON THE LATERAL SIDE OF THE PATIENTS TIBIA. SURGEON REMOVED ALL HARDWARE, CREATED AN OSTEOTOMY, THEN PUT IN A ZIMMER HINDFOOT NAIL AS WELL AS SYNTHES VA PROXIMAL TIBIA PLATE. PATIENT CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR ONE (1) 3.5 VA LCKNG SCR SLF-TPNG/SD/26. THIS IS REPORT 13 OF 14 FOR COMPLAINT PC-(B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 13388666 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REMOVAL OF VARIABLE ANGLE MEDIAL TIBIA PLATE AND CORRESPONDING SCREWS DUE TO NONUNION. THE MEDIAL PLATE WAS ORIGINALLY PUT ON THE LATERAL SIDE OF THE PATIENTS TIBIA. SURGEON REMOVED ALL HARDWARE, CREATED AN OSTEOTOMY, THEN PUT IN A ZIMMER HINDFOOT NAIL AS WELL AS SYNTHES VA PROXIMAL TIBIA PLATE. PATIENT CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR ONE (1) 3.5 VA LCKNG SCR SLF-TPNG/SD/26. THIS IS REPORT 4 OF 14 FOR COMPLAINT PC-(B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 13388661 ↗