HEALIX ADVANCE DYNATAPE DYNACORD 280718Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705031078), received between May 12, 2022 and May 12, 2022 — classified as 1 malfunction.

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 18, 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.

• MalfunctionMay 12, 2022Migration; Migration

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE ANCHOR ON THE 5.5 HLX ADV PK 2.5 DYNAT WHT DEVICE UNSEATED WHILE PASSING SUTURES THROUGH CUFF. ACCORDING TO THE REPORT, POOR QUALITY CORTICAL BONE CONTRIBUTED TO LACK OF ANCHOR SECURITY. IT WAS REPORTED THAT THE ANCHOR WAS RETRIEVED AND REMOVED AND NO FRAGMENTS GENERATED. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED SUCCESSFULLY BUT WITH A 10 MINUTE SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14376416 ↗