VA-LCP 02.118.012Recalls & reported problems
Synthes GmbH · 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/14 HOLES/RIGHT · Class 2 · Implant
All models of VA-LCP (256)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982037787), received between Jan 4, 2022 and Oct 21, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (1 report).
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
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Nonunion/Delayed-union Bone Fracture2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2022, TIBIA NON-UNION PLUS HARDWARE REMOVAL OF PLATES AND BROKEN SCREWS OCCURRED. THERE WAS PATIENT CONSEQUENCES. THERE WAS TIBIA NON UNION + BROKEN 2.7MM SCREWS. THIS REPORT IS FOR ONE (1)2.7/3.5 VA-LCP MED DSTL TIBIA PL/14 H/RT. THIS IS REPORT 2 OF 14 FOR COMPLAINT (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 15652177 ↗InjuryJan 4, 2022Break; Break
IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A HARDWARE REMOVAL AND REVISION ORIF TIBIA PROCEDURE. IT WAS NOTED THAT PREOPERATIVE X-RAYS REVEAL BENT OR BROKEN 2.7/3.5MM MEDIAL DISTAL TIBIA PLATE, 14 HOLE, RIGHT. PATIENT IS INSENSATE NEUROPATHIC, DIABETIC. PATIENT IS UNAWARE OF HOW PLATE WAS BENT OR BROKEN. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: UNK - SCREWS: TRAUMA(PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS FOR (1) 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/14 HOLES/RIGHT . THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Nonunion/Delayed-union Bone Fracture
MAUDE report 13158931 ↗
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