A&E Medical / Thorecon™ Box Cable Plate Kit (inc. screws & cable) 94-1400-04 (UDI 10841291107224)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841291107224), received between Mar 23, 2023 and Mar 23, 2023 — classified as 2 injuries.

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 18, 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.

• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THE PATIENT WAS REVISED OF A STERNAL CONSTRUCT DUE TO ABNORMAL TISSUE RESPONSES OVER THE PLATE SITES. THE SURGEON INDICATED THE POSSIBILITY OF A METAL ALLERGY REACTION WITHIN THE TISSUE. AT THE TIME OF THE REVISION, THE STERNAL HEALING HAD BEEN ACHIEVED WELL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Wound Dehiscence

  MAUDE report 16598341 ↗
• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS FURTHER REPORTED THROUGH MEDICAL RECORDS THAT THE PATIENT HAD AN INITIAL CORONARY ARTERY BYPASS GRAFT PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A SUPERFICIAL AND DEEP WOUND DEBRIDEMENT WITH REMOVAL OF STERNAL PLATING SYSTEM AND VAC PLACEMENT SURGERY DUE TO WOUND DEHISCENCE, SURGEON REPORTED POSSIBLE METAL ALLERGY REACTION WITHIN THE TISSUE, APPROXIMATELY THREE (3) MONTHS POST-IMPLANTATION. DURING THE PROCEDURE THE BONE WAS FOUND TO BE HEALTHY AND STABLE. THERE WAS INFLAMMATORY TISSUE NOTED AROUND EACH STERNAL PLATE. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Wound Dehiscence

  MAUDE report 16598330 ↗