LCP 241.096SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982165855), received between Aug 30, 2021 and Sep 16, 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 16, 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 HAD A NONUNION, LATERAL FRACTURE. LCP CLAVICULAR HOOK PLATE 3.5 WAS USED WITH GRAFTON PASTE, 5CC. THERE WAS A REOPERATION DUE TO DPS IMPLANTS AND HARDWARE REMOVAL, PATIENT COULD FEEL IMPLANT. UNION WAS NOT ACHIEVED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES 1 (ONE) DEVICE. THIS REPORT IS FOR (1) 3.5 LCP CLAV HK PL 6H 18 HK DPTH/73/RT-S. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Skin Inflammation/ Irritation

  MAUDE report 12484704 ↗
• 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 TWENTY (20) WEEKS. THE PATIENT OUTCOME IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 3.5MM LCP CLAVICLE HOOK PL 6H 18MM HOOK DEPTH/73MM/RT-STER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12474402 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A FRACTURE FIXATION FOR A LATERAL FRACTURE UTILIZING LCP CLAVICULAR HOOK PLATE 3.5. UNION WAS ACHIEVED AFTER 16 WEEKS. REOPERATION WAS DONE DUE TO HARDWARE REMOVAL; PATIENT COULD FEEL IMPLANT. CONCOMITANT DEVICES REPORTED: UNK - SCREWS: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 6). THIS REPORT IS FOR ONE (1) 3.5 LCP CLAV HK PL 6H 18 HK DPTH/73/RT-S. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12387235 ↗