LCP 02.108.341Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982029959), received between Jul 7, 2020 and Oct 21, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2021Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PEDIATRIC HIP PLATE PROXIMAL LOCKING SCREWS PULLED OUT. THE PATIENT HAD CORRECTIVE OSTEOTOMY OF FEMUR SURGERY. LOCKING SCREWS HAD BEEN TIGHTENED WITH TORQUE LIMITER BUT SCREWS ARE PULLED OUT AND THE PATIENT IS IN THE PAIN. THE PATIENT IS REQUIRED REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR ONE (1) PEDIATRIC LCP HIP PLATE 5.0MM/130°/5 HOLES. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 12673537 ↗
• InjuryOct 21, 2021Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PEDIATRIC HIP PLATE PROXIMAL LOCKING SCREWS PULLED OUT. THE PATIENT HAD CORRECTIVE OSTEOTOMY OF FEMUR SURGERY. LOCKING SCREWS HAD BEEN TIGHTENED WITH TORQUE LIMITER BUT SCREWS ARE PULLED OUT AND THE PATIENT IS IN THE PAIN. THE PATIENT IS REQUIRED REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR ONE (1) PEDIATRIC LCP HIP PLATE 5.0MM/130°/5 HOLES. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 12673517 ↗
• InjuryOct 21, 2021Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PEDIATRIC HIP PLATE PROXIMAL LOCKING SCREWS PULLED OUT. THE PATIENT HAD CORRECTIVE OSTEOTOMY OF FEMUR SURGERY. LOCKING SCREWS HAD BEEN TIGHTENED WITH TORQUE LIMITER BUT SCREWS ARE PULLED OUT AND THE PATIENT IS IN THE PAIN. THE PATIENT IS REQUIRED REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR ONE (1) PEDIATRIC LCP HIP PLATE 5.0MM/130°/5 HOLES. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 12673485 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF ONE (1) LOCKING COMPRESSION PLATE (LCP) PEDIATRIC HIP PLATE, THREE (3) UNKNOWN CORTEX SCREWS AND THREE (3) UNKNOWN LOCKING SCREWS DUE TO CYST GROWTH IN THE PROXIMAL FEMUR. IT WAS REVISED TO FEMORAL RECON NAIL. DURING SURGERY THE REAMING ROD WITH BALL TIP THAT WAS OPEN WAS NOT PEEL PACK PROPERLY THE WIRE BECAME CONTAMINATED DUE TO UNEVEN TEARING/PEEL AWAY. A NEW REAMING WIRE WAS USED. THE PATIENT OUTCOME WAS AS PLANNED. CONCOMITANT DEVICES REPORTED: SCREWS: CORTEX (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 3); SCREWS: LOCKING (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 3). THIS PRODUCT COMPLAINT, (B)(4) IS RELATED TO (B)(4). THIS (B)(4) CAPTURES THE POST OP EVENT IN WHICH A REMOVAL SURGERY WAS DONE DUE TO CYST GROWTH AND (B)(4) CAPTURES THE INTRA-OP EVENT IN WHICH DURING REMOVAL SURGERY THE REAMING ROD WITH BALL TIP THAT WAS OPEN WAS NOT PEEL PACK PROPERLY, THE WIRE BECAME CONTAMINATED DUE TO UNEVEN TEARING/PEEL AWAY. THIS REPORT INVOLVES ONE (1) PEDIATRIC LCP HIP PLATE 5.0MM/130°/5 HOLES. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Cyst(s); No Code Available

  MAUDE report 10239352 ↗