NA 04.112.622SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982279279), received between Jul 19, 2023 and Oct 3, 2023 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K201321, K203414); they may or may not involve this specific model.

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.

• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: THIS PC IS RELATED TO (B)(4). (B)(4) REPORTS THE BREAKAGE OF THE SCREWS IN THE REMOVAL SURGERY. THIS PC REPORTS THE INFECTION AFTER THE PRIMARY SURGERY. IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT PRIMARY SURGERY FOR CLAVICLE FRACTURE WITH VA LCP CLAVICLE PLATE AND LOCKING SCREW. ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE AN INFECTION, SO AN UNKNOWN DATE, REMOVAL SURGERY WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VA-LCP CLAVIC PL 2.7 SHAFT CS2 LE TAN. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 17860762 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR CLAVICLE FRACTURE WITH VA LCP CLAVICLE PLATE 2.7. DUE TO INFECTION, THE PLATE WAS REMOVED ON (B)(6) 2023. THE INFECTION WAS DUE TO POSTOPERATIVE MANAGEMENT ISSUES WITH THE PATIENT AND WAS NOT CAUSED BY THE IMPLANT. THE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS2/ LEFT/ STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 17351531 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201321, K203414. One submission often covers many models, so check the product and lot details in each record.

• Z-1241-2024 · Jan 24, 2024 · Open, Classified
  VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S