LCP 02.112.082Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982033130), received between Aug 15, 2017 and Sep 17, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 SURGERY FOR A SHAFT FRACTURE UTILIZING AN LCP SUPERIOR CLAVICLE PLATE. THERE WAS A REOPERATION DUE TO HARDWARE REMOVAL- PATIENT COULD "FEEL" PLATE. THERE WAS A KNOWN UNION OF FRACTURE AFTER 6 WEEKS DURATION AND NO POST-OPERATIVE COMPLICATIONS REPORTED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNK - SCREWS: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR (1)3.5 LCP SUPERIOR CLAV PL/7 HOLE/RT/100. THIS REPORT IS 1 OF 9 FOR (B)(4).

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12491408 ↗
• InjurySep 16, 2021Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A FRACTURE FIXATION FOR A SHAFT FRACTURE UTILIZING LCP SUPERIOR CLAVICLE PLATE. UNION WAS ACHIEVED AFTER 20 WEEKS. PLATE DISPLACEMENT WAS REPORTED POST-OP. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS FOR (1) 3.5 LCP SUPERIOR CLAV PL/7 HOLE/RT/100. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12484554 ↗
• InjuryAug 15, 2017Break; Break

  IT WAS REPORTED ON (B)(6) 2017 A REVISION SURGERY WAS PERFORMED FOR A BROKEN 3.5 MM LCP SUPERIOR CLAVICLE PLATE/7 HOLE/RIGHT/100 MM DUE TO NON-UNION. THE PATIENT WAS EXPERIENCING PAIN IN RIGHT CLAVICLE AND IT WAS DISCOVERED THAT THE IMPLANTED CLAVICLE PLATE WAS BROKEN. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY, THERE WERE NO SURGICAL DELAYS, NO FRAGMENTS WERE GENERATED FROM BROKEN DEVICE, NO ADDITIONAL X-RAYS TAKEN AND NO OTHER MEDICAL INTERVENTION REQUIRED. A NEW DEPUY SYNTHES CLAVICLE PLATE WAS IMPLANTED INTO THE PATIENT AND THE PATIENT STATUS WAS REPORTED AS STABLE. CONCOMITANT PART: SCREWS (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY SEVEN). THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

  Patient problems: Failure of Implant; No Code Available; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 6795833 ↗