LCP 226.621Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982159151), received between Jun 26, 2018 and Oct 4, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THE REVISION OF TIBIA PLATE DUE TO NONUNION. SCREWS WERE BROKEN AND LEFT IN BODY. THE PROCEDURE SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. FRAGMENTS WERE GENERATED BUT THEY WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. PATIENT CONSEQUENCES WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 4.5MM BROAD LCP PLATE 12 HOLES/224MM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15537029 ↗
• InjuryOct 3, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A BROKEN LARGE FRAGMENT PLATE WITH TWELVE SCREWS. THE SURGEON PERFORMED REVISION SURGERY ON (B)(6) 2022 WHEREIN THE BROKEN PLATE AND 10 SCREWS WERE REMOVED. THIS REPORT INVOLVES ONE 4.5MM BROAD LCP® PLATE 12 HOLES/224MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15529749 ↗
• InjuryJun 26, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT FELL AND SUFFERED A DISPLACED COMMINUTED OBLIQUE RIGHT FEMORAL PERIPROSTHETIC SHAFT FRACTURE IN (B)(6) 2017. ON (B)(6) 2017, PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) AND WAS IMPLANTED WITH ONE (1) 10 HOLE SYNTHES LARGE.4.5 LCDCP, FIVE (5) 4.5 CORTICAL SCREWS, FIVE (5) 5.0 LOCKING SCREWS, AND THREE (3) SUPER CABLES. SURGERY WAS SUCCESSFUL, HOWEVER, PATIENT SUFFERED FROM A 300 CC BLOOD LOSS AND WAS TRANSFUSED WITH TWO UNITS OF BLOOD. PATIENT WAS STABLE FOLLOWING SURGERY. ON (B)(6) 2018, THE PLATE BROKE AND THE PATIENT HAD SURGERY TO REMOVE THE HARDWARE ON (B)(6) 2018. PATIENT WAS REVISED TO ONE (1) 12 HOLE SYNTHES 4.5MM LCP PLATE, ONE (1) DBX PUTTY, ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 40MM, ONE (1) 5.0MM VARIABLE ANGLE LOCKING SCREW/SELF-TAPPING 44MM, TWO (2) 5.0MM VARIABLE ANGLE LOCKING SCREW/SELF-TAPPING 32MM SCREWS, FOUR (4) 5.0MM VARIABLE ANGLE LOCKING SCREW/SELF-TAPPING 36MM SCREWS, TWO (2) 5.0MM VARIABLE ANGLE LOCKING SCREW/SELF-TAPPING 34MM SCREW, AND ONE (1) 5.0MM VARIABLE ANGLE LOCKING SCREW/SELF-TAPPING 48 MM SCREW. SHE RECEIVED 2UNITS OF BLOOD. THE SURGERY WAS COMPLETED SUCCESSFULLY. POST-OPERATIVELY, PATIENT COMPLAINED O

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7638765 ↗