VA-LCP 02.124.409Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982042798), received between Nov 20, 2017 and Feb 6, 2020 — classified as 5 injuries.

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.

• InjuryFeb 6, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE THE BROKEN VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE AND TWO (2) OF THE 4.5 MM CORTEX SCREWS ON FEMUR. THE PATIENT EXPERIENCED PAIN, NONUNION AND DELAYED HEALING. ORIGINALLY, THE PATIENT HAD AN INITIAL SURGERY LAST (B)(6) 2018 WHERE THE REPORTED DEVICES WERE IMPLANTED. DURING THE REVISION PROCEDURE, ALL THE ORIGINAL IMPLANTS WERE SUCCESSFULLY REMOVED INCLUDING THE GENERATED FRAGMENTS FROM THE BROKEN DEVICES. FRAGMENTS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PATIENT WAS REVISED TO A RETROGRADE/ ANTEGRADE FEMORAL NAIL (RAFN). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT STATUS WAS GOOD. CONCOMITANT DEVICES REPORTED: UNKNOWN VA LOCKING SCREWS, (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 4), UNKNOWN VA CANNULATED LOCKING SCREWS, (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 4), UNKNOWN CORTEX SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 01 OF 03 OF (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 9677109 ↗
• InjurySep 24, 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 EXPLANTATION OF THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CONDYLAR PLATE AND 9 UNKNOWN SCREWS DUE TO NON-UNION AND DELAYED HEALING. INITIALLY THE PATIENT WAS IMPLANTED WITH THE REPORTED DEVICES IN (B)(6) 2019. THE PATIENT WAS REVISED TO A NEW PLATE (SAME SIZE PLATE 02.124.409) SUCCESSFULLY. THERE WAS NO SURGICAL DELAY REPORTED. PATIENT STATUS IS UNKNOWN. THIS IS REPORT 1 FOR 10 PC-(B)(4).

  Patient problems: No Code Available

  MAUDE report 9109045 ↗
• InjuryAug 23, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO NON-UNION OF DISTAL FEMUR PERIPROSTHETIC FRACTURE, THE PLATE WAS REMOVED WITH 9 UNKNOWN SCREWS. INITIALLY, THE 8 HOLE LEFT VARIABLE ANGLE LCP CURVED CONDYLAR PLATE AND UNKNOWN SCREWS WERE IMPLANTED ON (B)(6) 2018. THERE WERE 5 UNKNOWN LOCKING SCREWS DISTALLY OF UNKNOWN LENGTHS, 3 UNKNOWN LOCKING SCREWS AND 1 UNKNOWN CORTICAL SCREW PROXIMAL TO THE FRACTURE, ALSO OF UNKNOWN LENGTHS. THE REVISION SURGERY AND THE INITIAL IMPLANTATION OF THE DEVICES WERE PERFORMED BY DIFFERENT SURGEONS. THE PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/LEFT. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8925282 ↗
• InjuryJun 5, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO A ONE (1) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE AND ONE (1) 5.0MM CANNULATED LOCKING SCREW 85MM WERE BROKEN AND NONUNION OF THE LEFT FEMUR. THE PLATE BROKE AT THE JUNCTION OF THE SECOND COMBI HOLE. AN 85MM 5.0 CANNULATED LOCKING SCREW AS BROKE AT THE SCREW HEAD. THE OTHER CANNULATED LOCKING SCREWS AND CORTEX SCREWS WERE REMOVED BUT NOT BROKEN. IT WAS REVISED WITH ANOTHER PLATE. INITIAL DATE OF THE SURGERY WAS ON (B)(6) 2019. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: 5.0MM CANNULATED LOCKING SCREWS 85MM (PART # 02.205.085, LOT # UNKNOWN, QUANTITY 2) 5.0MM CANNULATED LOCKING SCREWS 80MM (PART # 02.205.080, LOT # UNKNOWN, QUANTITY 2), 5.0MM CANNULATED LOCKING SCREW 35MM (PART # 02.205.035, LOT # UNKNOWN, QUANTITY 1), 4.5MM CORTEX SCREW SELF-TAPPING 36MM (PART # 214.836, LOT # UNKNOWN, QUANTITY 3), 4.5MM CORTEX SCREW SELF-TAPPING 44MM (PART # 214.844, LOT # UNKNOWN, QUANTITY 2), 4.5MM CORTEX SCREW SELF-TAPPING 46MM (PART # 214.846, LOT # UNKNOWN, QUANTITY 1), 4.5MM CORTEX SCREW SELF-TAPPING

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 8670764 ↗
• InjuryNov 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL AND REVISION ON (B)(6) 2017. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2017, TO REPAIR A LEFT COMMINUTED DISTAL FEMUR FRACTURE. SUBSEQUENTLY, THE PATIENT SUSTAINED A FALL WHICH BENT THE ORIGINALLY IMPLANTED PLATE AND CAUSED A LOSS OF REDUCTION. NOTHING UNTOWARD OCCURRED DURING THE REVISION PROCEDURE. REMOVED HARDWARE INCLUDED: ONE PLATE (BENT) AND A COMBINATION OF 4.5 MM CORTEX AND 5.0 MM VARIABLE ANGLE (VA) LOCKING SCREWS (ALL INTACT). THE FEMUR WAS RE-REDUCED, AND THE PATIENT WAS REVISED TO A NEW LONGER PLATE AND SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THERE WAS NO SURGICAL DELAY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. CONCOMITANT DEVICES REPORTED: UNKNOWN 4.5 MM CORTEX SCREWS (QUANTITY - 6), UNKNOWN 5.0 MM VA LOCKING SCREWS (QUANTITY - 4). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7044926 ↗

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