VA-LCP 02.127.230Recalls & reported problems
Synthes GmbH · 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/8H/147MM/RIGHT · Class 2 · Implant
All models of VA-LCP (256)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982043542), received between Jun 25, 2018 and Jul 9, 2025 — classified as 2 injuries, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Break1
- Corroded1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- Nonunion/Delayed-union Bone Fracture1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2025Break; Corroded; Material Deformation; Break; Corroded; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE WARPED, THREADS ARE BROKEN AND ARE RUSTED. THERE WAS NO PATIENTS CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22459614 ↗InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A SURGEON WILL BE REVISING A PROXIMAL TIBIA BECAUSE OF A NONUNION ON (B)(6) 2023. THE ORIGINAL SURGERY WAS DONE ON (B)(6) 2012. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. THE HARDWARE WAS SUCCESSFULLY REMOVED AND REVISED WITH ANOTHER PLATE. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 3.5 VA PROX TIB PL SMALL BEND/8H/147/RT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 16875541 ↗InjuryJun 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REMOVAL OF ELEVEN (11) LOCKING SCREWS, FOUR (4) CORTEX SCREWS, ONE (1) CANNULATED SCREW, ONE (1) VARIABLE ANGLE LOCKING COMPRESSION (LCP) PROXIMAL TIBIA PLATE, AND ONE (1) LCP POSTEROMEDIAL PROXIMAL TIBIA PLATE DUE TO INFECTION. THERE WAS NO DELAY IN SURGERY. PATIENT OUTCOME WAS NOT REPORTED. THIS REPORT IS FOR ONE (1) 3.5 MM VA-LCP PROX TIBIA PLATE SMALL BEND/8H/147 MM/RIGHT. THIS IS REPORT 1 OF 5 FOR (B)(4).
Patient problems: No Code Available; Unspecified Infection
MAUDE report 7634247 ↗
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- 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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