LCP 240.045SRecalls & reported problems
Synthes GmbH · 4.5MM LCP® PROXIMAL TIBIA PLATE 12H/226MM/LEFT-STERILE · Class 2 · Implant
All models of LCP (367)
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 10886982164629), received between Jun 15, 2021 and Jun 15, 2021 — classified as 1 injury.
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 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.
InjuryJun 15, 2021Break; Break
IT WAS REPORTED THAT ON OR ABOUT (B)(6) 2019 THE PATIENT SUFFERED A FALL AND WAS IMPLANTED WITH 4.5 MM PROXIMAL TIBIAL PLATE AND SYNTHES SCREWS. ON OR ABOUT (B)(6) 2020 THE PATIENT DEVELOPED AN INFECTION AND WAS TREATED AND HOSPITALIZED. ON OR ABOUT (B)(6) 2020 AN X-RAY WAS TAKEN OF THE LEFT LOWER EXTREMITY WHICH REVEALED AN ACUTE FRACTURE IN THE 4.5 MM PROXIMAL TIBIAL PLATE. ON OR ABOUT (B)(6) 2020 THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE DEFECTIVE FRACTURED 4.5 MM PROXIMAL TIBIAL PLATE AND OTHER ASSOCIATED SCREWS. THIS COMPLAINT CAPTURES THE REVISION OF BROKEN PLATE AND IS RELATED TO (B)(4).. THIS COMPLAINT INVOLVES ONE (1) DEVICE. CONCOMITANT DEVICES: 4.5MM CORTEX SCREW SELF-TAPPING 28MM (PART # 214.828 LOT # UNKNOWN, QUANTITY# 1). 4.5MM CORTEX SCREW SELF-TAPPING 26MM (PART # 214.826, LOT # UNKNOWN, QUANTITY# 1). 5.0MM CANNULATED CONICAL SCREW 80MM (PART # 02.205.280 LOT # UNKNOWN, QUANTITY# 1). 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 60MM (PART # 212.221, LOT # UNKNOWN, QUANTITY# 1). 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 55MM (PART # 212.220, LOT # UNKNOWN, QUANTITY# 1). 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 26MM (P
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12003563 ↗
Other PLATE, FIXATION, BONE devices
- Lapiplasty System 2 SK14Treace Medical Concepts, Inc. · Plate, Fixation, Bone260 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page