LCP 03.108.036Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982071767), received between Nov 8, 2019 and Nov 8, 2019 — 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED (B)(6) 2019 THAT A VARIANT OSTEOTOMY OF THE PROXIMAL FEMUR OF A (B)(6) YEAR-OLD PATIENT WAS PERFORMED, THE SURGEON DECIDED TO PLACE A 2.7 ° PLATE 2.7 MM SYSTEM AND FIX THE PLATE WITH 2.7MM LOCKING SCREWS. AFTER PLACING THE PROXIMAL SCREWS AS INSTRUCTED BY THE TECHNIQUE, THE SURGEON PROCEED TO PERFORM THE DIAPHYSEAL FIXATION OF HIS PREFERENCE WITH LOCKING SCREWS. THE FIRST HOLE IS DRILLED AND THE SCREW IS PLACED. WHEN PLACING THE LCP DRILL GUIDE IN THE NEXT HOLE IN THE PLATE, THIS GUIDE FELL¿S DOWN. SINCE NO OTHER GUIDE IS AVAILABLE, THE SURGEON NECESSARILY DECIDES TO PLACE A CORTEX SCREW, WHICH WAS NOT ADEQUATE FOR THE TECHNIQUE THAT THE SURGEON HANDLES. PROCEDURE IS TERMINATED WITHOUT ANY OTHER COMPLICATIONS. BUT THE SURGEON SHOWS A LOT OF DISAGREEMENT; SINCE THE TEAM DOES NOT HAVE ANOTHER GUIDE, AND HE SAYS THAT THEY CAN PRESENT THIS TYPE OF INCIDENTS WHICH COULD BE SOLVED IN AN APPROPRIATE WAY IF THE SYSTEM HAD ANOTHER GUIDE AS THEY HAVE THE SYSTEM OF 3.5 AND 4.5 OF THE LCP PEDIATRIC. AT THE TIME OF THE INCIDENT, I TRY TO HANDLE THE SITUATION AND PROVIDE A SOLUTION WITH A TEAM ON THE STOCK OF THE D

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9297183 ↗