VA-LCP 02.124.415Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982042910), received between Dec 20, 2016 and Nov 29, 2022 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT HAD MAL-UNION, NON-UNION DISTAL FEMUR PLATING AND REVISION SURGERY. THE PATIENT HAD REMOVAL OF PLATE, VA CONDYLAR, LEFT AND QTY 4 SCREW 5.0 MM, VA LOCKING (QTY X1 BROKEN HEAD, ALL FRAGMENTS REMOVED), QTY 3 4.5MM CORTEX SCREW, QTY 1 3.5MM CORTEX SCREW, QTY 3 2.7 MM CORTEX SCREWS. NO ADDITIONAL INFORMATION WAS REPORTED. THIS REPORT IS FOR A 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT. THIS IS REPORT 1 OF 12 FOR (B)(4).

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

  MAUDE report 15880473 ↗
• MalfunctionDec 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, WHILE PLATING A DISTAL FEMUR THE VARIABLE ANGLE LOCKING SCREW ON THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE CROSS THREADED AND DID NOT LOCK INTO THE PLATE PROPERLY. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES (2) DEVICES. THIS REPORT IS FOR (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122456 ↗
• InjuryAug 12, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT A CORRECTIVE PROCEDURE TO REMOVE THE CONDYLAR PLATE. THIS WAS DUE TO A CURVE CONDYLAR PLATE FATIGUE AND THE PLATE WAS FOUND TO BE BROKEN AT THE METAPHYSEAL JUNCTION. THE REVISION SURGERY WAS FOR HARDWARE REMOVAL AND STABILIZATION OF THE FRACTURE. THE PATIENT WAS ORIGINALLY IMPLANTED WITH A 4.5MM VARIABLE ANGLE (VA)-LOCKING COMPRESSION PLATE CURVE CONDYLAR PLATE SYSTEM ON (B)(6) 2020 FOR REPAIR OF PERIPROSTHETIC DISTAL FEMUR FRACTURE VIA AN OPEN REDUCTION INTERNAL FIXATION (ORIF). ALL HARDWARE WAS REMOVED SUCCESSFULLY, AND A RETROGRADE FEMORAL NAIL WAS IMPLANTED. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/ 14 HOLE/ 301MM/ LEFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10396135 ↗
• MalfunctionAug 26, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, ONE OF MY PARTNERS AND MYSELF WERE GOING OVER THE VARIABLE ANGLE CONDYLAR SYSTEM AND WERE HOOKING UP 14 HOLE LEFT PLATE TO THE AIMING JIG AS A PRACTICE RUN. IT SEEMED THAT THE PLATE WAS NOT CONNECTING CORRECTLY TO THE BOLT AND MAYBE BOLT OR PLATE IS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTION HANDLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8930770 ↗
• InjuryJun 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO IMPLANT BREAKAGE, NON-UNION AND INFECTION OF A DISTAL FEMUR. ONE (1) VARIABLE CONDYLAR PLATE, ONE (1) OUT OF FIVE (5) CANNULATED VARIABLE LOCKING SCREWS WERE BROKEN AND THREE (3) OUT OF FOUR (4) CORTEX SCREWS WERE BROKEN. ALL HARDWARE WERE REMOVED AND ALL FRAGMENTS WERE SUCCESSFULLY REMOVED. THE PATIENT WAS REVISED TO AN EXTERNAL FIXATOR WITH PLACEMENT OF ANTIBIOTIC BEADS. THE ORIGINAL DATE OF SURGERY WAS ON (B)(6) 2018. THE BROKEN SCREWS CAUSED AN UNKNOWN DELAY IN THE CASE. PATIENT STATUS WAS UNKNOWN. THIS COMPLAINT INVOLVES 1 OF 5 FOR (B)(4).

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

  MAUDE report 8707129 ↗
• InjuryMay 21, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION DUE TO NON-UNION OF THE DISTAL FEMUR FRACTURE AND THE VARIABLE ANGLE (VA) LOCKING COMPRESSION (LCP) CURVED CONDYLAR PLATE WAS BROKEN. THE FRACTURE HAD TO BE REVISED WITH PLATE AND SCREWS. THERE ARE BROKEN SCREWS. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY AND AS WELL AS THE PATIENT OUTCOME. NO OTHER ADDITIONAL INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN) THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7529665 ↗
• MalfunctionFeb 15, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2017 TO TREAT A DISTAL FEMUR FRACTURE. DURING THE PROCEDURE, THE SURGEON WAS TRYING TO INSERT THE 4.5MM VARIABLE ANGLE-LOCKING COMPRESSION (VA-LCP) CURVED CONDYLAR PLATE WITH A MINIMALLY INVASIVE TECHNIQUE. TO INSERT THE PLATE, THE SURGEON ATTACHED AN INTERLOCKING BOLT, INTERLOCKING NUT AND INSERTION HANDLE TO THE PLATE. WHILE PUSHING THE INSERTION HANDLE TO INSERT THE PLATE, THE CONNECTING SCREW AND THE HOLE IN THE PLATE BECAME STRIPPED. IT WAS CONFIRMED THAT THERE WERE NO ISSUES WITH THE INTERLOCKING BOLT AND INSERTION HANDLE. BACK UP DEVICES WERE READILY AVAILABLE TO COMPLETE THE PROCEDURE. NO FRAGMENTS WERE GENERATED. THERE WAS A REPORTED FIVE (5) MINUTE SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. CONCOMITANT DEVICES REPORTED: NUT FOR INTERLOCKING BOLT FOR VA LCP CONDYLAR INSERTION HANDLE (PART #03.231.006, LOT #UNKNOWN, QUANTITY 1), INSERTION HANDLE FOR 4.5MM VA-LCP CONDYLAR PLATE (PART #03.231.001, LOT #UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6332727 ↗
• InjuryDec 20, 2016Break; Break

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2016 FOR A PERIPROSTHETIC FRACTURE OF THE LEFT LEG WHERE A 4.5MM VARIABLE-ANGLE LOCKING COMPRESSION (VA-LCP) CURVED CONDYLAR PLATE AND AN UNKNOWN NUMBER OF SCREWS WERE IMPLANTED. POSTOPERATIVELY, WHILE TAKING A WALK A FEW DAYS AGO THE PATIENT FELT THE PLATE BROKE. IT WAS CONFIRMED VIA X-RAY ON (B)(6) 2016 THAT THE PLATE BROKE AT THE FRACTURE SITE. REVISION SURGERY WAS PERFORMED ON (B)(6) 2016, WHERE A BROKEN PLATE AND AN UNKNOWN NUMBER OF INTACT SCREWS WERE REMOVED. THE SURGEON REDUCED THE FRACTURE AGAIN BY IMPLANTING A NEW PLATE AND RE-USING THE SAME INITIAL SCREWS THAT WERE JUST REMOVED. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS REPORTED AS FINE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART/LOT NUMBERS: UNKNOWN, QUANTITY: UNKNOWN) THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 6190885 ↗

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