REFLEX HYBRID 48674014Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540392954), received between Dec 11, 2017 and Aug 7, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2020Material Deformation; Migration; Material Deformation; Migration

  IT WAS REPORTED THAT THERE WAS A 'LITTLE DAMAGE' TO THE HEAD OF A REFLEX HYBRID FIXED ANGLE BONE SCREW WHICH CAUSED THE SCREW TO PASS THROUGH THE PLATE INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER SCREW AND A 30 MINUTE SURGICAL DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10382248 ↗
• InjuryAug 5, 2020Migration; Migration

  A PHYSICIAN REPORTED THAT THE SECURING MECHANISM OF A REFLEX HYBRID TWO-LEVEL PLATE FAILED AND TWO REFLEX HYBRID FIXED ANGLE BONE SCREWS PLACED AT C7 BACKED-OUT; THE ORDER OF EVENTS IS NOT KNOWN AT THIS TIME. THE PATIENT HAS BEEN REVISED. THIS REPORT REPRESENTS THE SECOND OF THE TWO SCREWS.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10367189 ↗
• InjuryAug 5, 2020Migration; Migration

  A PHYSICIAN REPORTED THAT THE SECURING MECHANISM OF A REFLEX HYBRID TWO-LEVEL PLATE FAILED AND TWO REFLEX HYBRID FIXED ANGLE BONE SCREWS PLACED AT C7 BACKED-OUT; THE ORDER OF EVENTS IS NOT KNOWN AT THIS TIME. THE PATIENT HAS BEEN REVISED. THIS REPORT REPRESENTS ONE OF THE TWO SCREWS.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10367187 ↗
• InjuryDec 11, 2017Migration or Expulsion of Device; Device Slipped; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE SCREW FROM INITIAL PROCEDURE BACKED OUT. SURGEON PERFORMED REVISION PROCEDURE TO REMOVE THE SCREW AND REPLACE WITH REVISION SCREW.

  Patient problems: Injury; No Code Available

  MAUDE report 7106249 ↗