REFLEX HYBRID 48510300Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327270747), received between Mar 14, 2022 and Mar 14, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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.

• MalfunctionMar 14, 2022Material Separation; Material Separation

  A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF A REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR FRACTURED WHEN REMOVING A SCREW FROM THE PLATE AND THE REFLEX HYBRID PLATE HOLDER IS, "COMING APART." THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE REFLEX HYBRID PLATE HOLDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13763153 ↗