LCP 239.997Recalls & reported problems
Synthes GmbH · 4.5MM LCP® MEDIAL PROXIMAL TIBIA PLATE 16H/LEFT 322MM · 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 10886982164094), received between Jan 20, 2017 and Jan 20, 2017 — 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 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Failure of Implant1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 20, 2017Break; Break
IT WAS REPORTED THAT A REVISION SURGERY TOOK PLACE ON (B)(6) 2016 FOR A BROKEN 4.5 MM LOCKING COMPRESSION PLATE (LCP) MEDIAL PROXIMAL TIBIA PLATE. IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY IMPLANTED APPROXIMATELY THREE (3) MONTHS PRIOR TO (B)(6) 2016 (EXACT DATE UNKNOWN) WITH PLATE AND AN UNKNOWN QUANTITY OF UNKNOWN SCREWS. IT WAS REPORTED THAT THE PATIENT WAS NON-COMPLIANT; WALKING AND BEARING WEIGHT ON THE OPERATED LEG. THE PLATE BROKE AT ONE SCREW HOLE AND THE OTHER SIDE OF THE PLATE WAS BENT. THE PATIENT WAS REVISED TO A TIBIA NAIL. ALL OTHER IMPLANTS WERE REMOVED INTACT. THERE WAS NO HARM TO PATIENT DURING THE REVISION SURGERY OR SURGICAL DELAY. CONCOMITANT DEVICES REPORTED: SCREW. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: Failure of Implant; No Code Available
MAUDE report 6266671 ↗
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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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