VA-LCP 02.107.102Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982029249), received between Dec 4, 2018 and Dec 15, 2023 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K120070); 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.

• MalfunctionDec 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, IT WAS FOUND THAT THE MOST DISTAL LOCKING HOLE THREADS WOULD NOT LOCK AFTER A SCREW WAS INSERTED. THERE WAS NO REPORTED SURGICAL DELAY AND NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM/3.5MM VA-LCP PROXIMAL OLECRANON PL 2H/LT/73MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18335875 ↗
• MalfunctionJul 21, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, THE LOCKING SCREW IN QUESTION WAS BEING PUT INTO AN OLECRANON PLATE, AND THE SCREW WOULD NOT TIGHTEN INTO THE VA LOCKING HOLE. IT STRIPPED OUT. THE SCREW WAS VITAL, SO THE PROCEDURE WAS CONTINUED USING ANOTHER SCREW AND PLATE WITH NO DELAY. THERE WAS NO ADVERSE PATIENT OUTCOME, NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM/3.5MM VA-LCP PROXIMAL OLECRANON PL 2H/LT/73MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15078451 ↗
• InjuryApr 19, 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 UNDERWENT HARDWARE REMOVAL PROCEDURE DUE TO DISCOMFORT. THE DEVICES EXPLANTED WERE ONE (1) 2.7MM/3.5MM VA-LCP PROXIMAL OLECRANON PLATE, ONE (1) 2.0MM VAL CONDYLAR PLATE, TWO (2) 3.5MM CORTEX SCREWS, FOUR (4) 2.7MM VA LOCKING SCREWS AND FIVE (5) 2.0MM VA LOCKING SCREWS. ALL IMPLANTS WERE REMOVED INTACT AND BONE HAD SUCCESSFULLY HEALED. THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM VA-LCP PROXIMAL OLECRANON PL 2H/LT/73MM. THIS IS REPORT 1 OF 13 FOR COMPLAINT (B)(4).

  Patient problems: Discomfort

  MAUDE report 14142023 ↗
• MalfunctionJan 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE OPEN REDUCTION INTERNAL FIXATION LEFT OLECRANON FRACTURE, THE SURGEON REMARKED VARIABLE ANGLE LOCKING SCREW WOULD NOT LOCK INTO THE THIRD MOST PROXIMAL HOLE OF VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) OLECRANON PLATE. THE SURGEON LEFT BOTH IMPLANTS IN THE PATIENT. THERE WAS 5 MINUTES SURGICAL DELAY. PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT INVOLVES ONE (1) 2.7MM/3.5MM VA-LCP PROXIMAL OLECRANON PL 2H/LT/73MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11219628 ↗
• MalfunctionOct 23, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING OPEN REDUCTION AND INTERNAL FIXATION OF PROXIMAL ULNA THE VARIABLE ANGLE LOCKING SCREW WOULD NOT LOCK INTO THE THIRD MOST PROXIMAL HOLE OF VARIABLE-ANGLE LOCKING COMPRESSION PLATE (VA-LCP) PROXIMAL OLECRANON. THE SURGEON LEFT BOTH IMPLANTS IN THE PATIENT. THERE WAS A TWO (2) MINUTES SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. PATIENT WAS GOOD. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10728644 ↗
• InjuryMay 1, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REMOVAL OF VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) PROXIMAL OLECRANON PLATE AND UNKNOWN SCREWS DUE TO ASEPTIC LOOSENING AND INFECTION. THE SURGEON ORIGINALLY TRIED USING A LONG CANNULATED SCREW THROUGH THE PROXIMAL ULNA TO FIXATE THE PROXIMAL PIECE. THAT DIDN¿T HOLD WELL ENOUGH AND ADD THE OLECRANON PLATE. THERE WAS A PATIENT CONSEQUENCE. (B)(4) CAPTURED THE 2ND REVISION WHERE IN ALL THE DEVICES WERE REMOVED DUE ASEPTIC LOOSENING AND INFECTION, (B)(4) CAPTURES THE 1ST REVISION WHERE IN ADDITIONAL IMPLANT WERE IMPLANTED THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) PROXIMAL OLECRANON PLATE SINCE ON THE ORIGINAL SURGERY THE UNKNOWN CANNULATED SCREW THAT USED FIXATE THE PROXIMAL PIECE DID NOT HOLD WELL ENOUGH. THIS REPORT IS FOR ONE 2.7MM/3.5MM VA-LCP PROXIMAL OLECRANON PL 2H/LT/73MM. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS 1 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10019107 ↗
• InjuryJul 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 A HARDWARE REMOVAL OF ONE (1) VARIABLE ANGLE OLECRANON PLATE, FIVE (5) UNKNOWN LOCKING SCREWS, AND TWO (2) UNKNOWN CORTEX SCREWS DUE TO INABILITY TO HEAL WOUND. THE PATIENT WAS HAVING ISSUES HEALING HER INCISION. THE FRACTURE HEALED COMPLETELY. PLATE AND SCREWS CAME OUT WITHOUT INCIDENT. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM VA-LCP PROXIMAL OLECRANON PLATE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 8824156 ↗
• InjuryDec 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT NOT ALL THE DEVICES WERE REMOVED. IT IS UNKNOWN WHICH SPECIFIC DEVICES WERE REMOVED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8128399 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120070. One submission often covers many models, so check the product and lot details in each record.

• Z-0124-2016 · Sep 28, 2015 · Terminated
  Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes