LCP 02.112.080Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982033093), received between Mar 31, 2020 and Sep 21, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (1 report).

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 4 most recent of 4 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 FOR A SHAFT FRACTURE UTILIZING AN LCP ANTERIOR CLAVICLE PLATE. POSTOPERATIVELY, THE PATIENT HAD RECURRENT SHOULDER DISLOCATIONS. THERE WAS A UNION OF FRACTURE FOR ABOUT SIX (6) WEEKS DURATION. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN LCP ANTERIOR CLAVICLE PLATE. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Joint Dislocation

  MAUDE report 12507746 ↗
• 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 SHAFT FRACTURE UTILIZING A LCP SUPERIOR CLAVICLE PLATE. REOPERATION WAS DUE TO HARDWARE REMOVAL DUE TO PLATE IRRITATION REPORTED BY THE PATIENT. THERE WAS A UNION OF FRACTURE IN ABOUT 12 WEEKS DURATION. NO POSTOPERATIVE COMPLICATIONS REPORTED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 3.5 LCP SUPERIOR CLAV PL/6 HOLE/RT/85. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12489229 ↗
• MalfunctionSep 2, 2020Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Scratched Material; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Scratched Material

  IT WAS REPORTED THAT ON (B)(6) 2020, THE 3.5MM LOCKING COMPRESSION PLATE (LCP) SUPERIOR CLAVICLE PLATE WAS NOTICED TO BE DAMAGED UPON DELIVERY. THE PRODUCT PACKAGING RIPPED AND PLATE SCRATCHED. THE PACKAGE ENVELOPE WAS ALSO DAMAGED AND THE LOCKING HOLE APPEARED TO BE DAMAGED. THERE WERE NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.5MM LCP SUPERIOR CLAVICLE PLATE/6 HOLE/RIGHT/85MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10484757 ↗
• InjuryMar 31, 2020Adverse 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 HARDWARE REMOVAL OF A LOCKING COMPRESSION SUPERIOR CLAVICLE PLATE AND UNKNOWN SCREWS DUE TO NONUNION. THE PLATE AND SCREWS WERE IMPLANTED ON AN UNKNOWN DATE. THE SURGEON REPLACED WITH A LONGER PLATE. THERE WERE SIX (6) SCREWS WERE INVOLVED WITH UNKNOWN SIZES. ALL WERE EXPLANTED EASILY WITH SCREWDRIVER. THE PROCEDURE OUTCOME IS UNKNOWN. THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 9903921 ↗