LCP 439.954SRecalls & reported problems
Synthes GmbH · 3.5MM TI LCP® MEDIAL PROXIMAL TIBIA PLATE 4H/RT 93MM-STER · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982219398), received between May 22, 2025 and May 22, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A REMOVAL SURGERY OF THE TIBIA PLATE AND THE LOCKING SCREWS FOR PROXIMAL TIBIA WHICH WERE INSERTED ON (B)(6) 2024. THE SURGEON TRIED TO REMOVE THE LOCKING SCREWS, HOWEVER THE PLATE LOCK WAS HARD, AND THE TIP OF THE SCREWDRIVER WAS TWISTED AND BROKEN, SO TIP OF THE SCREWDRIVER WAS LEFT IN THE SCREWHEAD. AFTER THAT HAPPENED, THE SURGEON BROKE THE PART IN QUESTION WITH A CARBIDE DRILL TO SEPARATE THE PLATE AND THE LOCKING SCREWS, THEN REMOVED THE LOCKING SCREWS FROM INSIDE OF BONE WITH A HOSPITAL OWNED VISE-GRIP INSTEAD OF THE SCREWDRIVER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22074336 ↗
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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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