REFLEX HYBRID 48651230Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540534804), received between Feb 24, 2016 and Jan 10, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT; LOCKING RING ON PRODUCT BROKE UPON SCREW INSERTION. DR. DID NOT OVER ANGLE SCREWS. TWO PLATE MALFUNCTIONED IN SAME CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7180376 ↗
• MalfunctionJan 10, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT; LOCKING RING ON PRODUCT BROKE UPON SCREW INSERTION. DR. DID NOT OVER ANGLE SCREWS. TWO PLATE MALFUNCTIONED IN SAME CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7180374 ↗
• MalfunctionJul 31, 2017Adverse Event Without Identified Device or Use Problem; Break; Mechanical Jam; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT WHILE INSERTING THE LAST SCREW ON A PLATE THE SURGEON NOTICED THE SCREW WASN'T GOING BELOW THE RING. THE SURGEON TRIED REDIRECTING THE SCREW TWO TIMES AND THE MEDIAL PART OF THE RING IN THE HOLE WAS STILL NOT ABLE TO BE SEEN. THE SURGEON WAS UNSURE IF THE RING WAS PRESENT AND THEREFORE DECIDED TO REMOVE THE PLATE. THE SURGEON SAW THAT THERE WAS A RING BUT THE RING WAS WEDGED/JAMMED AND THERE WAS NO GIVE. NEW PLATE SAME SIZE WAS IMPLANTED. NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. ADDITIONALLY, WHILE REMOVING THE SCREW TO REMOVE THE PLATE, THE TIP OF THE REVISION DRIVER BROKE. ALL BROKEN FRAGMENTS WERE RETRIEVED AND THE TIP OF THE DRIVER REMAINS IN THE SCREW. THE DRIVER HAS BEEN USED SEVERAL TIMES.¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6755575 ↗
• MalfunctionJun 22, 2017Migration or Expulsion of Device

  IT WAS REPORTED THAT; SURGEON PERFORMED A C3-C5 ACDF ON (B)(6) 2017 UTILIZING REFLEX HYBRID. IN THE PATIENT'S FOLLOW UP SCANS, IT CAN BE SEEN THAT THE SCREW INSERTED AT THE C3 LEVEL HAS PASSED THROUGH THE PLATE AND LOCKING MECHANISM. THE PLATE IS NOW MIGRATING ANTERIORLY. AT THIS TIME, THE PATIENT IS NOT EXPERIENCING ANY DISCOMFORT OR PAIN, BUT THE FACT THE SCREW IS NO LONGER ATTACHED TO THE PLATE IS A CONCERN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6659893 ↗
• MalfunctionDec 2, 2016Mechanical Problem; Material Deformation; Mechanical Problem; Device Operates Differently Than Expected; Material Deformation

  IT WAS REPORTED THAT THE GOLD LOCKING RING ON 30MM PLATE WAS EXTRACTED DURING REMOVAL OF SCREW, HAD TO REMOVE THE PLATE AND REPLACE TO ACHIEVE FINAL TIGHTENING/LOCKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6142589 ↗
• MalfunctionFeb 24, 2016Material Deformation; Malposition of Device; Material Deformation

  IT WAS REPORTED THAT A DRILL WAS USED ON POWER WITH VARIABLE DRILL GUIDE, 30MM PLATE 4.0X14MM VARIABLE SELF-TAPPING SCREW. INSERTED THE SCREWS WITH STAB AND GRAB DRIVER. UPON FINAL TIGHTENING WITH GOLD DRIVER, TWO SCREWS WENT COMPLETELY THROUGH THE PLATE. UPON INSPECTION AFTER REMOVAL IT WAS IDENTIFIED THAT THE RIM JUST BELOW THE HEAD OF THE SCREW WAS STRIPPED OFF OF THE SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5458131 ↗