LCP 02.112.523Recalls & reported problems
Synthes GmbH · 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/10H/LEFT/187MM · 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 10886982034618), received between Dec 14, 2022 and Dec 14, 2022 — 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 18, 2026.
Most reported problems
Device problems
- Break1
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.
InjuryDec 14, 2022Break; Break
IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT WENT TO THE OR FOR REMOVAL OF BROKEN HARDWARE AND A NONUNION TIBIA. THE FRACTURE WAS NOT PROPERLY REDUCED AT THE OTHER HOSPITAL DURING THE ORIGINAL ORIF. PATIENT UNDERWENT REVISION PROCEDURE WITH IMPLANTATION OF TIBIAL NAIL. NO FURTHER INFORMATION WAS REPORTED. THIS REPORT IS FOR A 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/10H/LEFT/187MM. THIS IS REPORT 1 OF 13 FOR (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 15978820 ↗
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- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-MLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-MRT42Nuvasive 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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