LCP 240.047Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982164650), received between Mar 8, 2018 and Oct 7, 2020 — classified as 2 injuries.

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.

• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2020, DUE TO WOUND BREAKDOWN. ORIGINAL IMPLANT DATE UNKNOWN. THE PATIENT UNDERWENT REMOVAL OF ALL HARDWARE AND NO FRAGMENTS WERE GENERATED. ALL HARDWARE WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION.. THERE IS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS UNKNOWN. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: Wound Dehiscence

  MAUDE report 10642859 ↗
• InjuryMar 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A 4.5 MM LCP PROXIMAL TIBIA PLATE, 4.5 MM CORTEX SCREWS (QUANTITY OF 7), 5.0 MM CANNULATED LOCKING SCREWS (QUANTITY OF 3), 3.5 MM CORTEX SCREWS (QUANTITY OF 2) AND NORIAN ON (B)(6) 2014 TO TREAT A TIBIA PLATEAU FRACTURE. PATIENT COMPLAINED OF PAIN WHILE RUNNING AND UNDERWENT HARDWARE REMOVAL ON (B)(6) 2018. THE SURGEON STATED THAT THE PLATE WAS IMPLANTED SLIGHTLY ANTERIOR DISTALLY ON THE SHAFT OF THE TIBIA DURING THE ORIGINAL SURGERY AND MAY BE CONTRIBUTING TO PATIENT¿S PAIN. SURGEON ALSO STATED THAT THERE COULD BE A STRESS RISER AT THE DISTAL END OF THE PLATE. REPORTEDLY, THE PATIENT ONLY EXPERIENCES PAIN WHILE RUNNING. PATIENT HEALED. THE PLATE WAS REMOVED. THE SURGEON EXPERIENCED DIFFICULTY WITH SCREW REMOVAL. TWO OF THE PROXIMAL 5.0 MM CANNULATED LOCKING SCREWS AND TWO 3.5 MM CORTEX SCREWS WERE EXTREMELY DIFFICULT TO REMOVE. THE HEADS OF THE TWO 5.0 MM CANNULATED LOCKING SCREWS WERE CUT AWAY WITH A METAL CUTTING BURR. BOTH SHAFTS REMAINED IN THE PATIENT. THE THIRD 5.0 MM CANNULATED LOCKING SCREW WAS EASILY REMOVED. THE HEAD OF ONE OF THE 3.5 MM CORTEX SCREW BROKE OFF. THE HEAD WAS REMOVED AND THE SHAFT REMAINED IN THE PATIENT. T

  Patient problems: Pain

  MAUDE report 7324225 ↗