LCP 04.112.139Recalls & reported problems
Synthes GmbH · 2.7MM/3.5MM TI LCP LAT DISTAL FIBULA PLATE 4H/LEFT/86MM · 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 10886982103604), received between May 19, 2020 and May 19, 2020 — 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
- Skin Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF TITANIUM LOCKING COMPRESSION PLATE LATERAL DISTAL FIBULA PLATE 4H/LEFT BECAUSE OF SKIN IRRITATION AND POSSIBLE INFECTION. THE SURGEON REMOVED 5 UNKNOWN LENGTH TITANIUM 2.7 LOCKING SCREWS, 1 UNKNOWN LENGTH 3.5 CORTEX SCREW, AND 2 UNKNOWN LENGTH 3.5 LOCKING SCREWS. PATIENT ALSO HAD AN ARTHREX TIGHTROPE REMOVED. UPON REMOVAL, THE FRACTURE APPEARED HEALED TO THE SURGEON AND THERE WAS NO VISIBLE INFECTION. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS AND OUTCOME WAS GOOD AND FRACTURE APPEARED TO BE HEALED. THIS IS REPORT 1 OF 9 FOR (B)(4).
Patient problems: Skin Irritation
MAUDE report 10069460 ↗
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- 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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