NA 04.112.820SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982279712), received between Jan 22, 2025 and Jan 22, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2025Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2024 , THE PATIENT UNDERWENT DISTAL CLAVICLE FRACTURE OSTEOSYNTHESIS ON CLAVICLE FRACTURE WITH THE PRODUCTS IN QUESTION. THIS WAS THE FIRST TIME VA CHP HAD BEEN USED AT THE FACILITY. THE SURGERY WAS COMPLETED AFTER FIXATION WITH ZIP TIGHT AND ADDITIONAL FIXATION WITH VA CHP. HOWEVER, THE POSTOPERATIVE PHOTOGRAPHS SHOWED THAT THE HOOK DID NOT SEEM TO REST ON THE ACROMION, SO THE SURGEON CONFIRMED THIS AGAIN BY PALPATION, BUT THIS WAS NOT CLEAR, SO HE HAD TO REEXPLORE THE SURGICAL SITE TO CONFIRM. AS A RESULT, IT WAS CONFIRMED THAT THE HOOK WAS NOT FULLY RESTING ON THE ACROMION, SO ALL THE IMPLANTS WERE REMOVED, AND THE RE-FIXATION WITH THE PLATE WAS ABANDONED AND REINFORCED WITH A JAGUAR KNOT TO FINISH. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 60 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21213915 ↗