NA 04.124.416Recalls & reported problems
Synthes GmbH · 4.5MM TI VA-LCP CRVD CONDYLAR PLATE/16 HOLE/336MM/RIGHT · 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 10886982111043), received between Jun 26, 2023 and Jun 26, 2023 — 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
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2023Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT A CONDYLAR PLATE ON (B)(6) 2023. ON (B)(6) 2023, THE PLATE BROKE POSTOPERATIVELY. THE PLATE WAS REMOVED AND REPLACED WITH A NON-SYNTHES PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY, AND NO BROKEN FRAGMENTS WERE RETAINED. THE PATIENT STATUS WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 4.5MM TI VA-LCP CRVD CONDYLAR PLATE/16 HOLE/336MM/RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Failure of Implant
MAUDE report 17198371 ↗
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 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 STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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