VA-LCP 02.127.211Recalls & reported problems
Synthes GmbH · 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/4H/87MM/LEFT · Class 2 · Implant
All models of VA-LCP (256)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982043481), received between Apr 17, 2018 and Jul 31, 2023 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (3 reports).
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
Device problems
- Device-Device Incompatibility3
- Adverse Event Without Identified Device or Use Problem1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Code Available1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS ALSO REPORTED THAT THE SURGEON COMPLAINED ABOUT THE FIT OF THE MEDIAL PROXIMAL TIBIA PLATE. THE SURGEON ENDED UP ADJUSTING THE PLATE SLIGHTLY, AND PUT SCREWS IN TO MAKE THE PLATE FIT SLIGHTLY BETTER. HOWEVER, AFTER THE SURGERY IT WAS ALSO OBSERVED THAT THE PROXIMAL PART OF THE PLATE WAS SITTING SLIGHTLY POSTERIORLY EVEN THOUGH CLINICALLY WHICH SHE FELT IT NEEDED TO IN ORDER TO ACCOMMODATE THE FRAGMENT PATTERN EVEN THOUGH IT SEEMED DIRECTLY MEDIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17427199 ↗MalfunctionMar 8, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2023, DURING AN OPEN REDUCTION/INTERNAL FIXATION PROCEDURE, A VA PROXIMAL TIBIA PLATE WAS USED. WHILE DRILLING FOR THE KICK STAND HOLE, THE SCREW DID NOT LOCK. A CORTICAL SCREW WAS USED INSTEAD. A POSTERIOR MALLEOLUS L PLATE WAS USED POSTERIOR OFF LABEL, AND A SCREW DID NOT LOCK IN 2 OF THE 3 TOP HOLES. METAPHYSEAL SCREWS WERE USED INSTEAD. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/4H/87MM/LEFT. THIS IS REPORT 1 OF 4 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16504629 ↗MalfunctionApr 21, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT WHILE ATTEMPTING TO INSERT A 3.5 VA LOCKING SCREW INTO A VA LOCKING HOLE, THE SCREW WOULD NOT LOCK INTO THE PLATE. A 3.5 CORTEX SCREW WAS PLACED IN THE HOLE AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ADDITIONALLY, IT WAS REPORTED THAT A PERIARTICULAR REDUCTION FORCEPS WAS DIFFICULT TO OPEN. HOWEVER, IT OPENED FREELY ONCE IT WAS WET WITH IRRIGATION. IT WAS BELIEVED TO HAVE BIOBURDEN. THE FORCEPS REMAINED STIFF POSTOPERATIVELY AFTER WASHING. THIS REPORT IS FOR THE PLATE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14171716 ↗InjuryDec 5, 2019No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REMOVAL OF ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) PROXIMAL TIBIA PLATE AND SEVERAL UNKNOWN CORTEX AND LOCKING SCREWS DUE TO INFECTION OF THE LEFT KNEE AREA, OPEN WOUND AND EXPOSED PATELLA TENDON. THERE WERE NO ISSUES REMOVING THE HARDWARE AND IT IS UNKNOWN HOW MANY SCREWS WERE REMOVED. AFTER HARDWARE WAS REMOVED, THE PLAN WAS TO CLEAN AND DEBRIDE THE BONE, THE TISSUE AND PLACE ANTIBIOTIC CEMENT WITH A WOUND VAC. NO HARDWARE WAS IMPLANTED. ORIGINAL INJURY WAS A FRACTURE TO THE LEFT LEG PROXIMAL TIBIA PLATEAU. THE INJURY OCCURRED FIVE (5) MONTHS PRIOR (B)(6) 2019 WITH THE UNKNOWN EXACT DATE. THERE WAS A PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR ONE (1) 3.5 MM VA-LCP PROX TIBIA PLATE SMALL BEND /4H/ 87 MM/ LEFT. THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: No Code Available; Unspecified Infection
MAUDE report 9416732 ↗InjuryApr 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD A PROXIMAL TIBIA REVISION SURGERY PERFORMED ON (B)(6) 2018 FOR REMOVAL HARDWARE PROXIMAL TIBIA PLATE DUE TO PAIN. THE ONE (1) PROXIMAL TIBIA PLATE, FOUR (4) 3.5 MM VARIABLE ANGLE LOCKING SCREWS, AND THREE (3) 3.5 MM CORTEX SCREWS WERE REMOVED WHOLE AND INTACT. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2017. THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED. NO SURGICAL DELAY OR PATIENT HARM WERE REPORTED. PATIENT OUTCOME WAS REPORTED AS COMPLETE. THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: Pain
MAUDE report 7435943 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page