VA-LCP 02.107.204Recalls & reported problems
Synthes GmbH · 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/RT/116MM · Class 2 · Implant
All models of VA-LCP (256)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982029287), received between Mar 30, 2018 and Sep 25, 2026 — classified as 3 injuries, 3 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Device-Device Incompatibility3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Pain3
- Bone Fracture(s)1
- Muscular Rigidity1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Device-Device Incompatibility
It was reported that there was rust on items. The items are not able to be sterilized. The Locking holes in plates are compromised/did not lock in surgeries. There was no patient harm or surgical delay.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900180 ↗MalfunctionSep 25, 2026Device-Device Incompatibility
It was reported that there was rust on items. The items are not able to be sterilized. The Locking holes in plates are compromised/did not lock in surgeries. There was no patient harm or surgical delay.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900179 ↗InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2022 REMOVAL OF HARDWARE DUE TO PAIN. SCREWS AND PLATES . NO SURGICAL DELAYED DUE TO THIS EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. FRAGMENTS WERE GENERATED BUT IS UNKNOWN IF THEY WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.7/3.5 VA-LCP OLECRANON PL 4H/RT/116 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Pain
MAUDE report 15361717 ↗MalfunctionSep 3, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED ON THAT (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE VA LOCKING SCREW WOULD NOT LOCK INTO PLATE HOLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES TWO(2) DEVICES. THIS REPORT IS FOR (1) 2.7/3.5 VA-LCP OLECRANON PL 4H/RT/116. THIS REPORT IS 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12421634 ↗InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL EVENT DESCRIPTION LEGAL AND MEDICAL RECORDS RECEIVED. ON OR ABOUT (B)(6) 2019, PATIENT EXPERIENCED DISPLACEMENT, PAIN, STIFFNESS OF RIGHT ELBOW, DISPLACED FRACTURE RIGHT, REMOVAL OF RADIUS HEAD IMPLANT, REMOVAL OF HARDWARE OF THE OLECRANON AS WELL AS THE RADIAL HEAD, LYSIS OF ADHESION AND DEBRIDEMENT. PATIENT PRESENTS DUE TO CONTINUED STIFFNESS OF THE RIGHT ELBOW AND WORSENING RIGHT ELBOW PAIN. FEELS LIKE OCCUPATIONAL THERAPY WAS VIGOROUS AND CAUSE ELBOW PAIN TO OCCUR AFTER SURGERY WHICH NEVER RESOLVED. PRIOR TO THAT SESSION SHE REPORTS SHE HAD WRIST PAIN AND NUMBNESS WHICH THEN RADIATED INTO THE ELBOW. CT SCAN OF RIGHT ELBOW WAS DONE FOR REVIEW. REPORTS OCCASIONAL NUMBNESS IN THE FINGER. ALSO HAS PERSISTENT NECK PAIN AND STIFFNESS. THE PATIENT PRESENTS WITH COMPLAINTS OF GRADUAL ONSET. THIS COMPLAINT INVOLVES (1) DEVICE. RELATED PRODUCT COMPLAINT: (B)(4).
Patient problems: Bone Fracture(s); Muscular Rigidity; Pain
MAUDE report 11251964 ↗InjuryMar 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ELBOW AND TIBIA ON (B)(6) 2017. ON UNKNOWN DATE PATIENT REPORTED EXPERIENCING PAIN AT THE IMPLANT SITE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED ALL HARDWARE. HARDWARE REMOVED INCLUDED ONE (1) 2.7MM/3.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA LCP) OLECRANON PLATE, SIX (6) LOCKING SCREWS, TWO (2) CORTEX SCREWS, ONE (1) 4.5MM LCP PROXIMAL TIBIA PLATE, SEVEN (7) LOCKING SCREWS, AND TWO (2) CORTEX SCREWS. THIS REPORT IS FOR ONE (1) VA LCP OLECRANON PLATE. THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: Pain
MAUDE report 7387065 ↗
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 · TerminatedSynthes 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
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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