LCP 02.112.093Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982033277), received between Nov 3, 2020 and Dec 1, 2021 — classified as 3 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. 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.

• InjuryDec 1, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT HAD SURGERY TO INSTALL A SYNTHES 3.5 MM LC-DCP VARIABLE ANGLE CLAVICLE PLATE ON HIS LEFT CLAVICLE AFTER A CYCLING CRASH THAT LEFT HIM WITH A SEVERE BREAK. ON (B)(6) 2021, AS HE WAS REACHING UP, HE HEARD A POP AND IMMEDIATE SHARP PAIN, FOLLOWED BY CONSISTENT DULL ACHING PAIN FOR WEEKS. HE WENT TO SEE AN ORTHOPEDIC SURGEON ON (B)(6) 2021, WHERE THEY TOOK AN X-RAY, IT LOOKED LIKE THE PLATE HAD BROKEN. HE WAS SENT FOR A CT SCAN ON (B)(6) 2021 TO FURTHER CONFIRM THAT IT, IN FACT, WAS BROKEN. HE THEN HAD A SECOND SURGERY ON (B)(6) 2021 TO REMOVE THE BROKEN HARDWARE AND INSTALL A NEW PLATE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 3.5MM LCP SUPERIOR CLAVICLE PLATE W/LAT EXTN/7H/LT/120MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12909894 ↗
• 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 SHAFT FRACTURE UTILIZING LCP SUPERIOR CLAVICLE PLATE. DBM 5CC WAS USED AS AN ADDITIONAL SURGICAL INTERVENTION. A REOPERATION WAS DONE DUE TO HARDWARE REMOVAL, PATIENT COULD FEEL IMPLANT. UNION WAS ACHIEVED AFTER 8 WEEKS. NO POST-OPERATIVE COMPLICATIONS REPORTED. CONCOMITANT DEVICES REPORTED: UNK, SCREWS: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 4). THIS REPORT IS FOR (1) 3.5 LCP SUP CLAV PL LAT EXTN/7H/LT/120. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12388118 ↗
• InjuryNov 3, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION DUE TO A BROKEN LOCKING COMPRESSION PLATE (LCP) SUPERIOR CLAVICLE PLATE THAT WAS IMPLANTED ON AN UNKNOWN DATE TWO YEARS AGO. THERE WERE NO FRAGMENTS GENERATED FROM THE BROKEN DEVICE AND THE DEVICE WAS EASILY REMOVED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 3.5 MM LCP SUPERIOR CLAVICLE PLATE W/LAT EXTN/7H/LT/120MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10780510 ↗