VA-LCP 02.124.413SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982042880), received between Jan 21, 2019 and Sep 9, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). IT WAS REPORTED CLINICAL ADVERSE EVENTS WERE RECEIVED FOR BREAKAGE OF SCREWS AND NON-UNION. EVENT OCCURRED BETWEEN 3 MONTHS AND 12 MONTHS POSTOP. PATIENT STATUS/ OUTCOME: PATIENT RECOVERED WITHOUT PERSISTENT DAMAGE THIS REPORT IS FOR ONE 4.5 VA-LCP CRVD COND PL/12HOLE/266/LT-S FOR (B)(6). (B)(4) IS RELATED TO (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20173708 ↗
• InjuryJul 21, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GREAT BRITAIN AS FOLLOWS: PATIENT SUSTAINED PERIPROSTHETIC FRACTURE (PPF) BELOW FEMORAL NAIL IN MARCH AND WAS FIXED WITH VA CONDYLAR PLATE ON AN UNKNOWN DATE IN MARCH 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 1 OF 1 FOR (B)(4) THIS REPORT IS FOR A CONDYLAR PLATE THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15079869 ↗
• InjuryJun 7, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION OF LEFT SUPRACONDYLAR FEMUR WITH INTRA -ARTICULAR EXTENSION FOR A LEFT SUPRACONDYLAR FEMUR FRACTURE NONUNION WITH HARDWARE FAILURE DUE TO SWELLING, PLATE BREAKAGE AND NONUNION. CONCOMITANT DEVICE REPORTED: 4.5MM CORTEX SCREW SELF-TAPPING 36MM (PART # 214.836 LOT # UNKNOWN, QUANTITY# 1), 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/36MM (PART # 02.231.236 , LOT # UNKNOWN, QUANTITY# 1), 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/34MM (PART # 02.231.234 LOT # UNKNOWN, QUANTITY# 2), 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/36MM (PART # 02.231.236 , LOT # UNKNOWN, QUANTITY# 6), 4.5MM CORTEX SCREW SELF-TAPPING 80MM (PART # 214.880 , LOT # UNKNOWN, QUANTITY# 6). THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/12HOLE/266MM/LT-STER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 11952433 ↗
• MalfunctionOct 2, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE THREADED GUIDE WAS NOT DRILLING TO THE GUIDE. THE SURGEON USED A DIFFERENT VARIABLE ANGLE LOCKING COMPRESSION PLATE/12 HOLE/266 MM/LEFT. THE TIP OF THE FLEXIBLE SHAFT AND STARDRIVE SCREWDRIVER SHAFT WAS BENT AND THE MEDULLARY REAMER HEAD WAS BROKE INSIDE THE PATIENT. THE FRAGMENTS FROM THE DEVICE WERE BROKEN IN THE PATIENT, SURGERY WAS DELAYED ROUGHLY ABOUT TWENTY TO THIRTY (20-30) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10621395 ↗
• InjuryJan 21, 2019Device-Device Incompatibility; Device-Device Incompatibility

  THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT.

  Patient problems: No Code Available

  MAUDE report 8265041 ↗

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