REFLEX HYBRID 48511820Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327270945), received between Mar 8, 2021 and May 12, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2021Material Deformation; Material Deformation

  A COMPANY REPRESENTATIVE REPORTED THAT THREE REFLEX HYBRID QUICK TURN INSERTION DRIVERS DEFORMED AT THE TIP DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE FIRST OF THREE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813060 ↗
• MalfunctionMay 12, 2021Material Deformation; Material Deformation

  A COMPANY REPRESENTATIVE REPORTED THAT THREE REFLEX HYBRID QUICK TURN INSERTION DRIVERS DEFORMED AT THE TIP DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE SECOND OF THREE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813046 ↗
• MalfunctionMay 12, 2021Material Deformation; Material Deformation

  A COMPANY REPRESENTATIVE REPORTED THAT THREE REFLEX HYBRID QUICK TURN INSERTION DRIVERS DEFORMED AT THE TIP DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE THIRD OF THREE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813041 ↗
• MalfunctionMar 8, 2021Material Deformation; Material Deformation

  A PHYSICIAN REPORTED THAT THE TIP OF A REFLEX HYBRID QUICK TURN INSERTION DRIVER BENT WHILE LOADING THE SCREW ON THE BACK TABLE DURING SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY AND WITH NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11439981 ↗