LCP 241.903Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982167637), received between Jan 12, 2018 and Aug 14, 2023 — classified as 5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE HARDWARE REMOVAL PROCEDURE DUE TO INFECTION. DURING REMOVAL PROCEDURE ONE PROXIMAL HUMERUS PLATE, 5 CORTICAL SCREWS, 8 LOCKING SCREWS WERE EXPLANTED. MEDICAL INTERVENTION REQUIRED WERE LABS AND ANTIBIOTICS. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 17546367 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT FELL RESULTING IN A DISPLACED RIGHT PROXIMAL HUMERUS FRACTURE. ON (B)(6) 2009, THE PATIENT UNDERWENT AN OPEN TREATMENT OF RIGHT PROXIMAL HUMERUS FRACTURE WITH TUBEROSITY REPAIR. PLATE AND SCREWS WERE IMPLANTED. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED A REACTION AT THE SURGICAL SITE FOR FIVE (5) YEARS. THE PATIENT WANTS THE DEVICES REMOVED. AT THIS POINT NO REVISION PROCEDURE HAS BEEN REPORTED. CONCOMITANT DEVICES: 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 45MM (PART 212.119, LOT UNKNOWN, QUANTITY 3); 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 30MM (PART 212.111, LOT UNKNOWN, QUANTITY 1); 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 40MM (PART 212.117, LOT UNKNOWN, QUANTITY 1); 3.5MM CORTEX SCREW SELF-TAPPING 26MM (PART 204.826, LOT UNKNOWN, QUANTITY 3); 3.5MM CORTEX SCREW SELF-TAPPING 24MM (PART 204.824, LOT UNKNOWN, QUANTITY 1); 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 35MM (PART 212.114, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR AN LCP PLATE. THIS IS REPORT 1 OF 10 FOR (B)(4). AN ADDITIONAL DEVICE IS CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Reaction

  MAUDE report 9861791 ↗
• InjuryAug 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO NON-UNION OF THE PROXIMAL HUMERUS ON AN UNKNOWN DATE. A 5 HOLE LOCKING COMPRESSION PLATE (LCP) HUMERUS PLATE AND UNKNOWN SCREWS WERE REMOVED AND REPLACED WITH A 5 HOLE LONG PROXIMAL HUMERUS PLATE. THERE WAS NO REPORTED MALFUNCTION AGAINST THE EXPLANTED PLATE AND SCREWS. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY OR PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 3.5MM LCP PROXIMAL HUMERUS PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7754965 ↗
• InjuryJul 16, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE A BROKEN LOCKING COMPRESSION PLATE (LCP) PROXIMAL HUMERUS PLATE 5 HOLE. THE HARDWARE WAS REMOVED AND THE PATIENT WAS REVISED TO A LONGER LCP PROXIMAL HUMERUS PLATE. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE LCP PROXIMAL HUMERUS PLATE 5 HOLE ON (B)(6) 2018, AND AFTER REPEATED FALLS, THE PLATE BROKE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7691197 ↗
• InjuryJan 12, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT OSTEOSYNTHESIS OF PROXIMAL HUMERUS WITH A 3.5MM LOCKING COMPRESSION PLATE (LCP) PROXIMAL HUMERUS PLATE AND SEVEN (7) UNKNOWN SCREWS ON (B)(6) 2017. PROCEDURE WAS COMPLETED SUCCESSFULLY. POST-OPERATIVELY IT WAS NOTED THE PLATE WAS BROKEN. IT WAS ALSO NOTED THAT PATIENT BONE HAS NECROSIS. REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 WITHOUT ANY ISSUES. IMPLANTS WERE REMOVED. PATIENT WILL RECEIVE UNSPECIFIED ADDITIONAL TREATMENT PRIOR TO IMPLANTING NEW MATERIAL. THIS REPORT IS FOR ONE (1) 3.5MM LCP PROXIMAL HUMERUS PLATE (B)(4).

  Patient problems: Necrosis

  MAUDE report 7186520 ↗