LCP 02.112.511Recalls & reported problems
Synthes GmbH · 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/4H/LEFT/109MM · 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 10886982034496), received between Feb 14, 2018 and Feb 14, 2018 — 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
- No Code Available1
- Wound Dehiscence1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT REMOVAL OF ONE (1) SYNTHES 4-HOLE 3.5 MM LOCKING COMPRESSION PLATE (LCP) LOW BEND MEDIAL DISTAL TIBIA PLATE AND SEVEN (7) UNKNOWN SCREWS ON (B)(6) 2018 DUE TO AN OPEN WOUND OVER MEDIAL ANKLE AND AN EXPOSED MEDIAL PLATE. THE PATIENT ALREADY HAD AN ORTHOFIX RING FIXATOR ON THE LEFT TIBIA WHEN THEY UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION OF THE LEFT DISTAL TIBIA TO BE IMPLANTED WITH THE MEDIAL PLATE AND SEVEN UNKNOWN SCREWS CONSTRUCT ON (B)(6) 2017. SUBSEQUENTLY, THE PATIENT RETURNED TO THE OPERATING ROOM FOR REMOVAL OF THE MEDIAL PLATE AND ALL SCREWS DUE TO THE OPEN WOUND AND THE EXPOSED PLATE. THE SURGEON PLANNED TO REMOVE THE EXTERNAL FIXATOR AND THE MEDIAL PLATE. THE SURGEON MADE AN INCISION AND DRAINED ALL WOUNDS BEFORE REMOVING ALL HARDWARE SUCCESSFULLY. ALL HARDWARE WAS REMOVED INTACT. THE WOUND CARE AND THE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY, MULTIPLE X-RAYS (UNAVAILABLE) WERE TAKEN DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES AND THE PATIENT WAS REPORTED TO BE STABLE. CONCOMITANT DEVICES REPORTED: ORTHOFIX RING FIXATOR (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 3.5MM LCP LOW BEND
Patient problems: No Code Available; Wound Dehiscence
MAUDE report 7271166 ↗
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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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