VA-LCP 02.107.302Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982029331), received between Mar 30, 2018 and Jan 6, 2023 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT THE DEVICES IN 2016. THE PATIENT FOUND OUT THAT THERE WAS A PROBLEM WITH THE IMPLANTS APPROXIMATELY 2 MONTHS AGO WHEN HE WENT TO THE ER BECAUSE HIS ARM WAS BAD, AND X-RAYS WERE TAKEN. THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE HARDWARE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/LT/90MMM. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16113691 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) OLECRANON PLATE WILL BE REVISED ON (B)(6) 2021. THE PATIENT PULLED THE PROXIMAL FRAGMENT OUT OF THE SCREWS. REMOVAL IS DUE TO FAILED FIXATION. IT WAS UNKNOWN IF THE REVISION SURGERY WAS COMPLETED. THERE WAS PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES (11) DEVICES. THIS REPORT IS FOR (1) 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/LT/90MM. THIS IS REPORT 1 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12887753 ↗
• MalfunctionNov 23, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE, WHEN ATTEMPTING TO INSERT A 2.7 VA LOCKING SCREW, THE SURGEON WAS UNABLE TO GET THE SCREW ENGAGE INTO THE PLATE. THE LOCKING SCREW WAS ACCEPTED, AND MORE SCREWS WERE PUT IN AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES NOTED. THIS REPORT INVOLVES ONE (1) 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/LT/90MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863442 ↗
• InjurySep 30, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON PERFORMED AN ORIF OF THE LEFT OLECRANON SIX WEEKS AGO USING OUR DEPUY SYNTHES 2 HOLE LEFT VALCP OLECRANON PLATE. THE PROXIMAL FRAGMENT CUT OUT OF THE PLATE AND SCREW CONSTRUCT CAUSING A NON-UNION AND ONE HUNDRED PERCENT DISPLACEMENT OF THE PROXIMAL FRAGMENT. THE PATIENT UNLOCKED HER BRACE, GIVING HER TOO MUCH RANGE OF MOTION AND EXERCISE TOO EARLY, RESULTING IN THE TREATMENT FAILURE. THE SURGEON REVISED THE OLECRANON ON (B)(6) 2021 USING OUR 4 HOLE VALCP OLECRANON PLATE AND OSTEOCRETE BONE GRAFT FROM ANOTHER MANUFACTURER. HER BONE CUT OUT AWAY FROM THE SCREWS AND PULLED OFF THE PLATE. THE REVISION SURGERY WAS PERFORMED SUCCESSFULLY. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 2.7/3.5 VA-LCP OLECRANON PL 2H/LT/90. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12555746 ↗
• InjuryJun 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT A REVISION OF VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE OLECRANON PLATE DUE TO NONUNION. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: 2.0MM LCP(TM) ADAPTION PLATE 12 HOLES 81MM (PART NUMBER 247.362, LOT UNKNOWN, QUANTITY 1), SCREWS: TRAUMA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES 1 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/LT/90MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10178586 ↗
• MalfunctionJun 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, AN UNKNOWN LOCKING SCREW WOULDN'T LOCK INTO THE MOST PROXIMAL SCREW HOLES OF THE REPORTED VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) OLECRANON PLATE. THE PROCEDURE WAS COMPLETED BY LEAVING THE LOCKING SCREW IN THE SCREW HOLE UNLOCKED. THERE WAS A 2 MINUTE SURGICAL DELAY REPORTED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES 2 DEVICES. THIS REPORT IS FOR 1 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/LT/90MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10171840 ↗
• MalfunctionOct 11, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN ORTHOPEDIC PROCEDURE, THREE (3) VARIABLE ANGLE (VA) LOCKING SCREWS WOULD NOT LOCK INTO FOUR DIFFERENT SCREW HOLES OF THE VA LOCKING COMPRESSION PLATE (LCP) OLECRANON PLATE. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/LT/90MM. THIS IS REPORT 1 OF 4 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9178989 ↗
• InjuryDec 26, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018, THE VARIABLE ANGLE (VA) LOCKING SCREW WOULD NOT LOCK INTO ONE OF THE HOLES ON THE VA LOCKING COMPRESSION PLATE (LCP) OLECRANON PLATE. THE PLATE WAS STILL IMPLANTED AND THE SURGEON IMPLANT AN UNKNOWN CORTICAL SCREW IN THAT HOLE INSTEAD. THE PATIENT OUTCOME WAS NOT AFFECTED BUT THERE WAS A 10 MINUTE DELAY IN THE CASE. PROCEDURE OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM VA LCP OLECRANON PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8198105 ↗
• MalfunctionMar 30, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT PROCEDURE FOR AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OLECRANON FRACTURE. DURING THE PROCEDURE, A LOCKING SCREW WOULD NOT LOCK INTO THE LEFT OLECRANON PLATE. THE SURGEON TRIED TO INSERT THE SCREW IN ON POWER THEN SWITCHED TO MANUAL, BUT WAS STILL UNSUCCESSFUL. THE INTERFACE BETWEEN THE PLATE AND SCREW DID NOT LOCK INTO THE PLATE. THERE WAS A TWO-MINUTE SURGICAL DELAY TO OBTAIN ANOTHER OF THE SAME SCREW WHICH WAS INSERTED IN A DIFFERENT HOLE IN THE PLATE. THE PLATE AND TEN (10) SCREWS WERE IMPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS AS EXPECTED. CONCOMITANT DEVICES REPORTED: POWER SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/LT/90MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7385138 ↗

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