REFLEX HYBRID 48511820BRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327277012), received between Mar 17, 2017 and Sep 9, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2021Fracture; Fracture

  IT WAS REPORTED THAT AS THE SURGEON WAS ATTEMPTING TO BACK OUT A SCREW, THE TIP OF A REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT FRACTURED OFF INSIDE THE SCREW HEAD. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SCREW WAS REMOVED SUCCESSFULLY WITH ANOTHER DEVICE WITHOUT REPORTED SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12451068 ↗
• MalfunctionJun 21, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING SCREW INSERTION THE THREADS OF THE INNER SHAFT OF A REFLEX HYBRID QUICK TURN INSERTION DRIVER FRACTURED OFF AND REMAINED LODGED INSIDE A SCREW. THE SCREW WAS THEN REMOVED FROM THE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 3 MINUTE SURGICAL DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037292 ↗
• MalfunctionOct 28, 2018Fracture; Break; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF SCREWDRIVER SHAFT BROKE OFF INTO THE SCREWDRIVER/SCREW INTERFACE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8011427 ↗
• MalfunctionMar 22, 2017Fracture; Device Operates Differently Than Expected; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT THE DRAW ROD (HEAD) HAS FAILED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6425472 ↗
• MalfunctionMar 17, 2017Break; Detachment Of Device Component; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT THE DRAW ROD TIP FOR THE SCREWDRIVER BROKE OFF IN THE SCREW AFTER IT WAS IMPLANTED. THE SURGEON ATTEMPTED TO UNTHREADED THE DRAW ROD BUT AFTER HE REMOVED THE DRIVER HE NOTICED THE TIP WAS BROKEN AND STILL THREADED IN THE SCREW. HE LEFT THE SCREW IN THE PATIENT WITH THE TIP OF THE DRAW ROD.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6413211 ↗