LCP 02.112.515Recalls & reported problems
Synthes GmbH · 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/6H/LEFT/135MM · 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 10886982034533), received between Sep 2, 2021 and Sep 2, 2021 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT DISTAL TIBIA REVISION SURGERY DUE TO NON-UNION AND THREE (3) BROKEN 3.5MM CORTEX SCREWS IN THE PLATING CONSTRUCT. THE EXISTING 3.5MM LOCKING COMPRESSION PLATE (LCP) REMAINED IN PLACE. THE HEADS OF THE BROKEN 3.5MM CORTEX SCREWS WERE REMOVED; HOWEVER THE REMOVAL OF THE SCREW SHAFTS WAS NOT POSSIBLE AND THERE IS NO PLAN TO REMOVE THE BROKEN SCREW SHAFTS. THE PATIENT WAS REVISED WITH LCP ANTEROLATERAL PLATE AND THREE (3) 3.5MM SCREWS WHICH ARE INSERTED ALONG SIDE OF BROKEN SCREW SHAFTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/6H/LEFT/135MM. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 12415267 ↗
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- 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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