LCP 02.108.420Recalls & reported problems
Synthes GmbH · PEDIATRIC LCP CONDYLAR PLATE 5.0MM/90°/3 HOLES · Class 2 · Implant
All models of LCP (367)
Data updated Oct 18, 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 10886982030092), received between Jul 11, 2023 and Jul 11, 2023 — 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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2023, WHERE SYNTHES STAINLESS STEEL CANNULATED BONE SCREWS WERE USED. DURING THE PROCEDURE A NUMBER OF SYNTHES TRAUMA PRODUCTS WERE IMPLANTED, INCLUDING A HIP PLATE, CORTEX SCREWS AND SIDE SCREWS. POST-SURGERY, THE PATIENT HAS BEEN EXPERIENCING SYMPTOMS THAT LEAD THEM TO BELIEVE THEY MAY BE HAVING AN ALLERGIC REACTION TO THE IMPLANTED ITEMS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A PEDIATRIC LCP CONDYLAR PLATE 5.0MM/90°/3 HOLES. THIS IS REPORT 4 OF 7 FOR (B)(4).
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 17299986 ↗
Other Screw, fixation, bone devices
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- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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