LCP 02.112.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982032638), received between Nov 17, 2017 and Sep 10, 2021 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A FRACTURE FIXATION SURGERY FOR A SHAFT FRACTURE UTILIZING A VA-LCP ANTERIOR PLATE. THERE WAS A UNION OF FRACTURE AFTER12 WEEKS DURATION AND REPORTED POST-OPERATIVE COMPLICATION WAS PROLONGED PAIN . PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNK - SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 10). THIS COMPLAINT INVOLVES ELEVEN (11) DEVICES. THIS REPORT IS FOR (1)3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 4H/RT/81MM. THIS REPORT IS 1 OF 11 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12455343 ↗
• InjuryNov 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HARDWARE REMOVAL AND REVISION WAS PERFORMED ON (B)(6) 2017 DUE TO A NEW FRACTURE JUST OUTSIDE THE SITE OF AN EXISTING CLAVICLE PLATE. THE ORIGINAL PROCEDURE, A CLAVICLE FRACTURE REPAIR, WAS PERFORMED ON AN UNKNOWN DATE DUE TO A MOUNTAIN BIKING ACCIDENT. REMOVED HARDWARE INCLUDED: ONE (1) PLATE AND SEVEN (7) SCREWS, ALL INTACT. ALL DEVICES WERE EASILY REMOVED. NO REPORTED SURGICAL DELAYS, NO FRAGMENTS INVOLVED, NO ADDITIONAL X-RAYS REQUIRED. THE PATIENT WAS REVISED TO: ONE (1) 2.7 MM LOCKING COMPRESSION (LCP) PLATE AND AN UNKNOWN QUANTITY OF SCREWS. THE ORIGINAL FRACTURE SITE WAS NOTED TO BE FULLY HEALED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 3.5 MM LCP SUPERIOR ANTERIOR CLAVICLE PLATE WITH LATERAL EXTENSION. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7041864 ↗