NA 04.124.413Recalls & reported problems
Synthes GmbH · 4.5MM TI VA-LCP CRVD CONDYLAR PLATE/12 HOLE/266MM/LEFT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982110985), received between May 7, 2022 and May 7, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2022Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022. PATIENT HAS BOTH LEFT PROSTHETIC DISTAL FEMUR NONUNION; WAS TREATED WITH A VARIABLE ANGLE (VA) CONDYLAR PLATE. THERE WERE EIGHT LOCKING SCREWS, TWO CORTICAL SCREWS AND A PLATE. THE PLATE, ALL THE SCREWS, AND THE TOTAL BROKEN PARTS WERE REMOVED SUCCESSFULLY. THE PATIENT HAD TO STAY FOR THE SURGEON TO PERFORM A DISTAL FEMORAL REPLACEMENT. THIS COMPLAINT IS FOR A 4.5MM TI VA-LCP CRVD CONDYLAR PLATE/12 HOLE/266MM/LEFT. THIS IS REPORT 1 OF 11 FOR (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14321327 ↗
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
Other Plate, fixation, bone devices
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- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive 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-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-PRT42Nuvasive 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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