NA 02.231.275Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982062222), received between Apr 9, 2018 and Jul 21, 2022 — classified as 10 injuries.

The most frequently reported specific device problem is “Break” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (K083025, K110354); they may or may not involve this specific model.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT SUSTAINED PERIPROSTHETIC FRACTURE (PPF) BELOW FEMORAL NAIL IN (B)(6) AND WAS FIXED WITH VA CONDYLAR PLATE ON AN UNKNOWN DATE IN (B)(6) 2022. PATIENT WAS READMITTED APPROXIMATELY 3 MONTHS AFTER IMPLANT WITH PLATE FRACTURE. NO NEW TRAUMA. HAD BEEN MOBILIZING IN RESIDENTIAL HOME. NORMAL TO LOW BMI. FRACTURE NON-UNITED, BUT NO EVIDENCE OF INFECTION. REVISION OCCURRED (B)(6) 2022. THIS IS REPORT 2 OF 11 FOR (B)(4). THIS REPORT IS FOR A VA-LOCKING SCREW. THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15075275 ↗
• InjuryJun 24, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A ORIF DISTAL FEMUR PROCEDURE. IT WAS NOTED THAT THE PLATE BROKE AT HOLE NUMBER 8 AND ALSO THE 3 - 4.5MM CORTICAL SCREWS BROKE. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. IT IS UNKNOWN IF THE PROCEDURE IS COMPLETED. NO PATIENT CONSEQUENCES NOTED. DEVICES WERE INVOLVED: 214.836 (4.5MM CORTEX SCREW SELF-TAPPING 36MM); QUANTITY: 3; 02.231.275 (5.0 VA LOCKNG SCR SLF-TPNG/SD/75); QUANTITY: 5-6; A PLATE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 5.0 VA LOCKNG SCR SLF-TPNG/SD/75. THIS REPORT IS 9 OF 10 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12063895 ↗
• InjuryJun 24, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A ORIF DISTAL FEMUR PROCEDURE. IT WAS NOTED THAT THE PLATE BROKE AT HOLE NUMBER 8 AND ALSO THE 3 - 4.5MM CORTICAL SCREWS BROKE. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. IT IS UNKNOWN IF THE PROCEDURE IS COMPLETED. NO PATIENT CONSEQUENCES NOTED. DEVICES WERE INVOLVED: 214.836 (4.5MM CORTEX SCREW SELF-TAPPING 36MM), QUANTITY: 3, 02.231.275 (5.0 VA LOCKNG SCR SLF-TPNG/SD/75), QUANTITY: 5-6, A PLATE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 5.0 VA LOCKNG SCR SLF-TPNG/SD/75. THIS REPORT IS 10 OF 10 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12063875 ↗
• InjuryJun 24, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A ORIF DISTAL FEMUR PROCEDURE. IT WAS NOTED THAT THE PLATE BROKE AT HOLE NUMBER 8 AND ALSO THE 3 - 4.5MM CORTICAL SCREWS BROKE. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. IT IS UNKNOWN IF THE PROCEDURE IS COMPLETED. NO PATIENT CONSEQUENCES NOTED. DEVICES WERE INVOLVED: 214.836 (4.5MM CORTEX SCREW SELF-TAPPING 36MM), QUANTITY: 3, 02.231.275 (5.0 VA LOCKNG SCR SLF-TPNG/SD/75), QUANTITY: 5-6, A PLATE. THIS COMPLAINT INVOLVES (10) DEVICES. THIS REPORT IS FOR (1) 5.0 VA LOCKNG SCR SLF-TPNG/SD/75. THIS REPORT IS 8 OF 10 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12063873 ↗
• InjuryJun 24, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A ORIF DISTAL FEMUR PROCEDURE. IT WAS NOTED THAT THE PLATE BROKE AT HOLE NUMBER 8 AND ALSO THE 3 - 4.5MM CORTICAL SCREWS BROKE. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. IT IS UNKNOWN IF THE PROCEDURE IS COMPLETED. NO PATIENT CONSEQUENCES NOTED. DEVICES WERE INVOLVED: 214.836 (4.5MM CORTEX SCREW SELF-TAPPING 36MM); QUANTITY: 3; 02.231.275 (5.0 VA LOCKNG SCR SLF-TPNG/SD/75); QUANTITY: 5-6; A PLATE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 5.0 VA LOCKNG SCR SLF-TPNG/SD/75. THIS REPORT IS 7 OF 10 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12063868 ↗
• InjuryJun 24, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A ORIF DISTAL FEMUR PROCEDURE. IT WAS NOTED THAT THE PLATE BROKE AT HOLE NUMBER 8 AND ALSO THE 3 - 4.5MM CORTICAL SCREWS BROKE. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. IT IS UNKNOWN IF THE PROCEDURE IS COMPLETED. NO PATIENT CONSEQUENCES NOTED. DEVICES WERE INVOLVED: 214.836 (4.5MM CORTEX SCREW SELF-TAPPING 36MM); QUANTITY: 3; 02.231.275 (5.0 VA LOCKNG SCR SLF-TPNG/SD/75); QUANTITY: 5-6; A PLATE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 5.0 VA LOCKNG SCR SLF-TPNG/SD/75. THIS REPORT IS 2 OF 10 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12063845 ↗
• InjuryApr 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL FEMUR USING SYNTHES VA CONDYLAR PLATE AND SCREWS. THE OUTCOME OF THE SURGERY WAS A NONUNION. ON (B)(6) 2018 THE SURGEON PERFORMED A REVISION ORIF OF THE DISTAL FEMUR TO ADDRESS THE NONUNION. THE PLATES AND SCREWS WERE INTACT AND SUCCESSFULLY REMOVED. A BONE GRAFT WAS INSERTED AND A NEW SYNTHES VA CONDYLAR PLATE AND SCREWS WERE INSERTED IN THE PATIENT. THE REVISION WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THIS IS REPORT 8 OF 8 (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7408033 ↗
• InjuryApr 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL FEMUR USING SYNTHES VA CONDYLAR PLATE AND SCREWS. THE OUTCOME OF THE SURGERY WAS A NONUNION. ON (B)(6) 2018 THE SURGEON PERFORMED A REVISION ORIF OF THE DISTAL FEMUR TO ADDRESS THE NONUNION. THE PLATES AND SCREWS WERE INTACT AND SUCCESSFULLY REMOVED. A BONE GRAFT WAS INSERTED AND A NEW SYNTHES VA CONDYLAR PLATE AND SCREWS WERE INSERTED IN THE PATIENT. THE REVISION WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THIS IS REPORT 7 OF 8 (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7408005 ↗
• InjuryApr 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL FEMUR USING SYNTHES VA CONDYLAR PLATE AND SCREWS. THE OUTCOME OF THE SURGERY WAS A NONUNION. ON (B)(6) 2018 THE SURGEON PERFORMED A REVISION ORIF OF THE DISTAL FEMUR TO ADDRESS THE NONUNION. THE PLATES AND SCREWS WERE INTACT AND SUCCESSFULLY REMOVED. A BONE GRAFT WAS INSERTED AND A NEW SYNTHES VA CONDYLAR PLATE AND SCREWS WERE INSERTED IN THE PATIENT. THE REVISION WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THIS IS REPORT 6 OF 8 (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7407344 ↗
• InjuryApr 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL FEMUR USING SYNTHES VA CONDYLAR PLATE AND SCREWS. THE OUTCOME OF THE SURGERY WAS A NONUNION. ON (B)(6) 2018 THE SURGEON PERFORMED A REVISION ORIF OF THE DISTAL FEMUR TO ADDRESS THE NONUNION. THE PLATES AND SCREWS WERE INTACT AND SUCCESSFULLY REMOVED. A BONE GRAFT WAS INSERTED AND A NEW SYNTHES VA CONDYLAR PLATE AND SCREWS WERE INSERTED IN THE PATIENT. THE REVISION WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THIS IS REPORT 2 OF 8 (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7406656 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083025, K110354. One submission often covers many models, so check the product and lot details in each record.

• Z-1125-2014 · Feb 5, 2014 · Terminated
  Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plat
• Z-0401-2014 · May 29, 2013 · Terminated
  Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fra