LCP 241.085SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982165800), received between Sep 15, 2021 and Sep 21, 2021 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A LATERAL FRACTURE FIXATION UTILIZING 3.5MM LOCKING COMPRESSION PLATE (LCP) CLAVICULAR HOOK PLATE. UNION WAS ACHIEVED AFTER 16 WEEKS. HARDWARE REMOVAL WAS DONE AS PATIENT COULD FEEL THE IMPLANT. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 3.5MM LCP CLAVICLE HOOK PL 5H 15MM HOOK DEPTH/59MM/LT-STER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12506628 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A FRACTURE FIXATION FOR A LATERAL FRACTURE UTILIZING A LOCKING COMPRESSION PLATE (LCP) CLAVICULAR HOOK PLATE 3.5. THE PATIENT REPORTED BEING ABLE TO FEEL THE IMPLANT, AND SO THE PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE. IT WAS NOTED THAT UNION WAS ACHIEVED AFTER SIXTEEN (16) WEEKS. THIS REPORT IS FOR A LCP CLAVICULAR HOOK PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12474346 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A PROCEDURE FOR FRACTURE FIXATION TREATING LATERAL FRACTURE USING THE LCP CLAVICULAR HOOK PLATE IN QUESTION. THE PATIENT REQUIRED REVISION SURGERY ON AN UNKNOWN DATE AND THE HARDWARE WAS REMOVED. IT WAS STATED THAT THE PATIENT COULD FEEL THE IMPLANT. UNION WAS ACHIEVED AFTER SIXTEEN (16) WEEKS. THE PATIENT OUTCOME IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 3.5MM LCP CLAVICLE HOOK PL 5H 15MM HOOK DEPTH/59MM/LT-STER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12474334 ↗