LCP 241.094SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982165831), received between Sep 17, 2021 and Sep 21, 2021 — classified as 5 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 5 most recent of 5 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 FRACTURE FIXATION AND REPAIR OF AC JOINT FOR A LATERAL FRACTURE UTILIZING A 3.5MM LOCKING COMPRESSION (LCP) CLAVICULAR HOOK PLATE. THERE WAS A UNION OF FRACTURE AFTER 16 WEEKS DURATION AND NO POST-OPERATIVE COMPLICATIONS REPORTED. HARDWARE REMOVAL WAS DONE AS PATIENT COULD FEEL THE IMPLANT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 3.5MM LCP CLAVICLE HOOK PL 6H 15MM HOOK DEPTH/73MM/RT-STER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12506867 ↗
• 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 FRACTURE FIXATION AND REPAIR OF AC JOINT FOR A LATERAL FRACTURE UTILIZING AN LCP CLAVICULAR HOOK PLATE 3.5. THERE WAS NO UNION OF FRACTURE AND THERE WERE POST-OPERATIVE COMPLICATIONS REPORTED. THE PATIENT EXPERIENCED TRANSITION TO REVERSE TOTAL SHOULDER SECONDARY TO ARTHRITIS. PATIENT WAS REOPERATED DUE TO HARDWARE REMOVAL AND TRANSITION TO REVERSE TOTAL SHOULDER SECONDARY TO ARTHRITIS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN LCP CLAVICULAR HOOK PLATE 3.5. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Arthritis

  MAUDE report 12506204 ↗
• 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 FRACTURE FIXATION AND REPAIR OF AC JOINT SURGERY FOR A LATERAL FRACTURE UTILIZING AN LCP CLAVICULAR HOOK PLATE 3.5. THERE WAS A UNION OF FRACTURE AFTER SIXTEEN (16) WEEKS DURATION AND NO POST-OPERATIVE COMPLICATIONS REPORTED. PATIENT WAS REOPERATED DUE TO HARDWARE REMOVAL AND PATIENT COULD FEEL IMPLANT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN LCP CLAVICULAR HOOK PLATE 3.5. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12505584 ↗
• InjurySep 20, 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, AS PATIENT COULD FEEL IMPLANT. CONCOMITANT DEVICE REPORTED: UNKNOWN CORTEX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 6). THIS REPORT IS FOR (1) 3.5 LCP CLAV HK PL 6H 15 HK DPTH/73/RT-S. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12502427 ↗
• InjurySep 17, 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 LCP CLAVICULAR HOOK PLATE 3.5. A UNION WAS ACHIEVED AFTER 20 WEEKS. OSTEOPHYTES IN THE AC JOINT WERE OBSERVED INTRAOPERATIVELY. A REOPERATION WAS DONE DUE TO HARDWARE REMOVAL AND THE PATIENT COULD FEEL THE IMPLANT. CONCOMITANT DEVICES: UNKNOWN SCREWS: CORTEX (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 6). THIS REPORT IS FOR ONE (1) 3.5MM LCP CLAVICLE HOOK PL 6H 15MM HOOK DEPTH/73MM/RT-STER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12491106 ↗