LCP 02.120.701Recalls & reported problems
Synthes GmbH · 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATE 1H/69MM · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982040206), received between Nov 1, 2021 and Nov 1, 2021 — classified as 1 malfunction.
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
- 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.
MalfunctionNov 1, 2021Break; Break
IT WAS REPORTED THAT ON (B)(6) 2021, THE TIP OF THE DRILL BIT BROKE OFF DURING INSERTION OF THE UNK - SCREWS: 3.5 MM CORTEX. THE EVENT OCCURRED DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A LEFT PROXIMAL TIBIA FX. THE SURGEON WAS DRILLING THROUGH THE OBLONG HOLE OF A 3.5MM LCP POSTEROMEDIAL PLATE USING A 2.5MM DRILL BIT WITH THE 3.5MM NON-LOCKING DRILL GUIDE. THE ANGLE OF DIFFICULTY IN RELATION TO WHERE THE PLATE WAS POSITIONED AND HOW THE LEG WAS POSITIONED MADE IT DIFFICULT FOR THE SURGEON TO AIM THE DRILL BIT AT THE CORRECT ANGLE. HE DRILLED THROUGH THE OBLONG HOLE OF THE PLATE AND INTO THE NEAR AND FAR CORTEX WITHOUT COMPLICATION. AS THE SURGEON BACKED OUT AND RETRACTED THE DRILL BIT FROM THE FAR CORTEX, IT WAS NOTICED THAT THE TIP OF THE DRILL BIT WAS MISSING. AN X-RAY OF THE LEFT PROXIMAL TIBIA SHOWED THAT THE TIP OF THE DRILL BIT WAS JUST ANTERIOR OF THE PLATE IN THE OBLONG HOLE OF THE 3.5 MM LCP POSTEROMEDIAL PLATE. THE SURGEON THEN TOOK THE PLATE OFF AND PROCEEDED TO SEARCH FOR THE MISSING TIP OF THE 2.5MM DRILL BIT. AFTER SUCTIONING, SMALL NEEDLE-NOSE CLAMPS WERE USED IN RETRIEVING THE MISSING TIP OF THE 2.5MM DRILL BIT. HE THEN RE-POSITIONED THE 3.5MM LCP POSTER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12728028 ↗
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- 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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