LCP 03.108.033Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982071743), received between Jun 8, 2022 and Sep 19, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING A UNILATERAL OSTEOTOMY, WHILE ASSEMBLING THE GUIDE BLOCK IN THE POSITIONING DEVICE THE SCRUB NURSE REPORTED THAT THE GUIDE BLOCK KEPT SLIPPING OUT OF THE POSITION DEVICE. EVEN WHEN THE SCREW WAS TIGHTENED, THE BLOCK WAS STILL SLIDING AND MOVING. THE SCREW WAS LOOSENED AND TIGHTENED AGAIN, BUT THE SAME PROBLEM OCCURRED. THERE WAS NO PURCHASE BETWEEN THE GUIDE BLOCK AND THE POSITIONING DEVICE SO IT KEPT FALLING OUT VERY EASILY. THE SURGEON USED THE DEVICE BY HOLDING THE GUIDE BLOCK IN PLACE, BUT THEN STOPPED AND USED THE LOCKING TOWERS TO GUIDE INSTEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT OUTCOMES WERE REPORTED. THIS REPORT IS FOR A PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 2.7MM SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446125 ↗
• MalfunctionJun 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON MAY 16, 2022, THE K-WIRE BECAME STUCK IN THE AIMING BLOCK, DESIGNED FOR 2MM WIRES. THERE WAS A SURGICAL DELAY OF MORE THEN FIVE (5) MINUTES. A TOOL WAS USED TO REMOVE THE K-WIRE. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) AIMING BLOCK F/SCR Ø2.7 F/LCP PAEDIATRIC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14630821 ↗