REFLEX HYBRID 48694014Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04546540535108), received between Apr 25, 2016 and Mar 23, 2023 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2023Fracture; Migration; Fracture; Migration

  A COMPANY REPRESENTATIVE REPORTED THAT APPROXIMATELY 7 YEARS POST-OPERATIVELY IT WAS NOTICED VIA X-RAY THAT A REFLEX-HYBRID VARIABLE ANGLE SELF TAP BONE SCREW HAD FRACTURED AND MIGRATED. THE PATIENT REPORTED PAIN.

  Patient problems: Pain

  MAUDE report 16598292 ↗
• MalfunctionMay 7, 2021Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  A COMPANY REPRESENTATIVE REPORTED THAT INSERTION OF A 4.0 MM REFLEX SCREW AT LEFT C4 WOULD NOT FINAL LOCK. WHILE REMOVING THE SCREW, THE SECURING MECHANISM OF A FOUR-LEVEL REFLEX HYBRID PLATE FRACTURED. ALL SCREWS AND THE PLATE WERE REMOVED AND REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE 4.0 MM REFLEX SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11791162 ↗
• InjuryApr 10, 2020Migration; Migration

  IT WAS REPORTED THAT TWO REFLEX-HYBRID VARIABLE ANGLE SELF TAP BONE SCREWS BACKED OUT INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH A 1 HOUR SURGICAL DELAY USING REPLACEMENT DEVICES. THIS RECORD REPRESENTS SCREW 2 OF 2.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9950508 ↗
• InjuryApr 10, 2020Migration; Migration

  IT WAS REPORTED THAT TWO REFLEX-HYBRID VARIABLE ANGLE SELF TAP BONE SCREWS BACKED OUT INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH A 1 HOUR SURGICAL DELAY USING REPLACEMENT DEVICES. THIS RECORD REPRESENTS SCREW 1 OF 2.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9950507 ↗
• InjuryDec 16, 2019Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  A PHYSICIAN REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS ¿DISENGAGEMENT¿ OF A REFLEX HYBRID THREE-LEVEL PLATE FROM THE FOUR DISTAL SCREWS. DURING SURGERY, IT WAS NOTED THAT, ¿PROXIMAL SCREWS ATTACHED TO THE PLATE AND DISTAL SCREWS DISMANTLED WITHOUT BREAKAGE AND STILL ATTACHED TO THE BONE,¿ AND THAT, ¿IT IS POSSIBLE TO PASS THE SCREW THROUGH THE HOLES IN THE PLATE.¿ THIS RECORD REPRESENTS THE FOURTH OF THE FOUR SCREWS.

  Patient problems: Injury

  MAUDE report 9476425 ↗
• InjuryDec 16, 2019Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  A PHYSICIAN REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS ¿DISENGAGEMENT¿ OF A REFLEX HYBRID THREE-LEVEL PLATE FROM THE FOUR DISTAL SCREWS. DURING SURGERY, IT WAS NOTED THAT, ¿PROXIMAL SCREWS ATTACHED TO THE PLATE AND DISTAL SCREWS DISMANTLED WITHOUT BREAKAGE AND STILL ATTACHED TO THE BONE,¿ AND THAT, ¿IT IS POSSIBLE TO PASS THE SCREW THROUGH THE HOLES IN THE PLATE.¿ THIS RECORD REPRESENTS THE SECOND OF THE FOUR SCREWS.

  Patient problems: Injury

  MAUDE report 9476143 ↗
• InjuryDec 16, 2019Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  A PHYSICIAN REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS ¿DISENGAGEMENT¿ OF A REFLEX HYBRID THREE-LEVEL PLATE FROM THE FOUR DISTAL SCREWS. DURING SURGERY, IT WAS NOTED THAT, ¿PROXIMAL SCREWS ATTACHED TO THE PLATE AND DISTAL SCREWS DISMANTLED WITHOUT BREAKAGE AND STILL ATTACHED TO THE BONE,¿ AND THAT, ¿IT IS POSSIBLE TO PASS THE SCREW THROUGH THE HOLES IN THE PLATE.¿ THIS RECORD REPRESENTS THE FIRST OF THE FOUR SCREWS.

  Patient problems: Injury

  MAUDE report 9476142 ↗
• InjuryDec 16, 2019Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  A PHYSICIAN REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS ¿DISENGAGEMENT¿ OF A REFLEX HYBRID THREE-LEVEL PLATE FROM THE FOUR DISTAL SCREWS. DURING SURGERY, IT WAS NOTED THAT, ¿PROXIMAL SCREWS ATTACHED TO THE PLATE AND DISTAL SCREWS DISMANTLED WITHOUT BREAKAGE AND STILL ATTACHED TO THE BONE,¿ AND THAT, ¿IT IS POSSIBLE TO PASS THE SCREW THROUGH THE HOLES IN THE PLATE.¿ THIS RECORD REPRESENTS THE THIRD OF THE FOUR SCREWS.

  Patient problems: Injury

  MAUDE report 9476118 ↗
• MalfunctionApr 25, 2016Break; Detachment Of Device Component; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT UPON INSERTION OF THE SCREW WITH STAB AND GRAB DRIVER, THE LOCKING CLIP OF THE SCREW SHEARED OFF AND THE SCREW WAS ABLE TO ADVANCE COMPLETELY THROUGH THE PLATE AND INTO THE VERTEBRAL BODY. SINGLE BARREL VARIABLE DRILL GUIDE, ALONG WITH THE 14MM DRILL BIT ON POWER WAS USED TO PREPARE THE SCREW HOLE PRIOR TO SCREW INSERTION. THE SCREW WAS ABLE TO BE REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5606349 ↗