LCP 240.048SRecalls & reported problems
Synthes GmbH · 4.5MM LCP(TM) PROXIMAL TIBIA PL 16 HOLES/298MM RT-STERILE · 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 10886982164674), received between May 25, 2018 and May 25, 2018 — 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
- 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.
InjuryMay 25, 2018Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF A LOCKING COMPRESSION PLATE (LCP) PROXIMAL TIBIA PLATE AND UNKNOWN SCREWS DUE TO BROKEN PLATE ON (B)(6) 2018. IT IS UNKNOWN WHEN THE DEVICES WERE ORIGINALLY IMPLANTED. IMPLANTS WERE SUCCESSFULLY REMOVED. THERE WAS NO SURGICAL DELAY REPORTED. THERE WERE NO FRAGMENTS GENERATED FROM A BROKEN DEVICE AND DID NOT REQUIRE ANY MEDICAL INTERVENTIONS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS IN STABLE CONDITION. CONCOMITANT DEVICE: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR A 4.5MM LCP(TM) PROXIMAL TIBIA PL 16 HOLES/298MM RT-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 7545458 ↗
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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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