NA 04.124.409SRecalls & reported problems
Synthes GmbH · 4.5MM TI VA-LCP CRVD CONDYLAR PLATE/8H/195MM/LT-STER · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982110916), received between Nov 5, 2024 and Nov 5, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K110354); 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
- Device-Device Incompatibility1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 5, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A CASE USING OUR VA CURVED CONDYLAR DISTAL FEMUR PLATE, THE CONNECTING SCREW FOR THE AIMING ARM WAS ATTEMPTED TO BE ATTACHED WHEN IT WOULD NOT THREAD INTO THE PLATE. MULTIPLE CONNECTING SCREWS WERE TRIED AND IT WOULD STILL NOT THREAD IN. UNABLE TO USE THE AIMING ARM AND HAD TO DO "PERFECT CIRCLES" TO PUT THE SCREWS IN THE SHAFT OF THE PLATE. THIS MADE THE CASE LONGER THAN IT SHOULD HAVE BEEN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20610101 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K110354. One submission often covers many models, so check the product and lot details in each record.
- Z-1125-2014 · Feb 5, 2014 · TerminatedSynthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plat
- Z-0401-2014 · May 29, 2013 · TerminatedSynthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fra
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- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-MLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-MRT42Nuvasive Specialized Orthopedics, Inc. · Plate, 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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