VA-LCP 02.107.002SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982029232), received between Jan 2, 2018 and Jul 9, 2018 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OSTEOTOMY OF THE OLECRANON ON (B)(6) 2018 TO FIX THE HUMERUS. THE OSTEOTOMY WAS REPAIRED WITH AN OLECRANON PLATE, 2 CORTEX SCREWS, AND 4 VARIABLE ANGLE (VA) LOCKING SCREWS. ON (B)(6) 2018 THE PATIENT HAD A REMOVAL OF VARIABLE ANGLE LOCKING COMPRESSION PLATE DUE TO NON-UNION. IT WAS NOTED THAT THE PROXIMAL OLECRANON DID NOT HEAL AND THE PIECE OF BONE CAME OUT OF THE SCREW PLATE CONSTRUCT, AND PATIENT ALSO EXPERIENCED MALUNION AND DECREASED RANGE OF MOTION. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENTS' PROXIMAL OLECRANON WAS REMOVED AND THE PATIENT OUTCOME WAS STABLE. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Impaired Healing; Loss of Range of Motion; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7671411 ↗
• InjuryFeb 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT ORIGINAL PROCEDURE FOR OPEN REDUCTION OF INTERNAL FIXATION ON (B)(6) 2017. POST OPERATIVELY, A TIP OF BONE / OLECRANON WAS SEPARATED FROM THE PLATE. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2018. NO HARDWARE WAS REMOVED. SURGEON REPAIRED TIP OF OLECRANON WHICH WAS SEPARATED FROM PLATE WITH SUTURE. THE PLATE AND TEN (10) SCREWS WERE STILL IMPLANTED IN PATIENT AND WERE INTACT. REPORTER CONFIRMED THAT THERE WAS NO MALFUNCTION ASSOCIATED WITH PLATE AND THEN (10) SCREWS. THERE WAS NO DELAY IN PROCEDURE AND WAS COMPLETED SUCCESSFULLY WITHOUT ANY COMPLICATIONS. PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICES: SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QTY 10) . THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Code Available

  MAUDE report 7240851 ↗
• InjuryJan 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HARDWARE REMOVAL WAS PERFORMED ON (B)(6) 2017 DUE TO PATIENT COMPLAINTS OF PROMINENCE OF THE SHAFT PORTION OF A PROXIMAL ULNA PLATE. THE ORIGINAL PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE IN (B)(6) 2017. THE REMOVED HARDWARE INCLUDED ONE 2.7MM/3.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) PROXIMAL OLECRANON PLATE AND SIX SCREWS, ALL INTACT AND REMOVED WITHOUT INCIDENT. NO REPORTED SURGICAL DELAYS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: 3.5MM CORTEX SCREW SELF-TAPPING 24MM (PART 204.824, LOT NUMBER UNKNOWN, QUANTITY 1); 2.7MM VARIABLE ANGLE LOCKING SCREW SELF TAPING WITH T8 STARDRIVE RECESS 56MM (PART 02.211.056, LOT NUMBER UNKNOWN, QUANTITY 1); 2.7MM VARIABLE ANGLE LOCKING SCREW SELF TAPING WITH T8 STARDRIVE RECESS 22MM (PART 02.211.022, LOT NUMBER UNKNOWN, QUANTITY 1); 2.7MM VARIABLE ANGLE LOCKING SCREW SELF TAPING WITH T8 STARDRIVE RECESS 18MM (PART 02.211.018, LOT NUMBER UNKNOWN, QUANTITY 1); 2.7MM VARIABLE ANGLE LOCKING SCREW SELF TAPING WITH T8 STARDRIVE RECESS 16MM (PART 02.211.016, LOT NUMBER UNKNOWN, QUANTITY 1); 3.5MM LOCKING SCREW SELF TAPING WITH STARDRIVE (TM) RECESS 56

  Patient problems: Discomfort; Not Applicable

  MAUDE report 7157587 ↗

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