REFLEX HYBRID 48644014Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540534682), received between Feb 10, 2016 and Aug 30, 2019 — classified as 4 injuries, 1 malfunction.

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

• InjuryAug 30, 2019Device Slipped; Biocompatibility; Biocompatibility

  A PATIENT REPORTED THAT A REVISION SURGERY OCCURRED SOMETIME IN 2010, POSSIBLY TO ADDRESS, ¿SOME LOOSE OR FRACTURED SCREWS,¿ (PATIENT WAS UNCLEAR ON THE EVENT). FOLLOW-UP INFORMATION, INCLUDING PREOPERATIVE AND INTRAOPERATIVE NOTES, DOES NOT INDICATE THE PRESENCE OF LOOSE OR FRACTURED SCREWS. THE PHYSICIAN¿S NOTES (DATED 10 SEPTEMBER 2007) INDICATE THE PATIENT EXPERIENCED HEADACHES, A DECREASE OF SENSATION ON THE LEFT SIDE ALONG WITH, MODERATE LEFT SIDE PTOSIS,¿ AND, ¿LEFT-SIDED HORNER¿S SYNDROME.¿ THE PHYSICIAN ADDITIONALLY NOTED, ¿RIGHT PUPIL 2.5 MM DOWN TO 2 MM WITH LIGHT," AND, "LEFT PUPIL 2 MM DOWN TO 1.5 MM WITH LIGHT.¿ THE OPERATIVE REPORT (DATED 01 SEPTEMBER 2010) STATES THAT THE PATIENT WAS NOTED TO HAVE, ¿PERSISTENT CERVICAL AND OCCIPITAL PAIN.¿ PRE-OPERATIVE IMAGING SHOWED, ¿PRESENCE OF PSEUDOARTHROSIS WITH LUCENCY AROUND HER SCREWS AND A PAUCITY OF INTERBODY SUPPORT." THIS REPORT CAPTURES THE FOURTH OF FOUR REFLEX HYBRID BONE SCREWS. REPORTS HAVE BEEN FILED SEPARATELY FOR ASSOCIATED DEVICES.

  Patient problems: Neck Pain; Ptosis

  MAUDE report 8952407 ↗
• InjuryAug 30, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Unclear Information; Biocompatibility; Unclear Information

  A PATIENT REPORTED THAT A REVISION SURGERY OCCURRED SOMETIME IN 2010, POSSIBLY TO ADDRESS, ¿SOME LOOSE OR FRACTURED SCREWS,¿ (PATIENT WAS UNCLEAR ON THE EVENT). FOLLOW-UP INFORMATION, INCLUDING PREOPERATIVE AND INTRAOPERATIVE NOTES, DOES NOT INDICATE THE PRESENCE OF LOOSE OR FRACTURED SCREWS. THE PHYSICIAN¿S NOTES (DATED (B)(6) 2007) INDICATE THE PATIENT EXPERIENCED HEADACHES, A DECREASE OF SENSATION ON THE LEFT SIDE ALONG WITH, ¿MODERATE LEFT SIDE PTOSIS,¿ AND, ¿LEFT-SIDED HORNER¿S SYNDROME¿. THE PHYSICIAN ADDITIONALLY NOTED, ¿RIGHT PUPIL 2.5 MM DOWN TO 2 MM WITH LIGHT," AND, "LEFT PUPIL 2 MM DOWN TO 1.5 MM WITH LIGHT.¿ THE OPERATIVE REPORT (DATED (B)(6) 2010) STATES THAT THE PATIENT WAS NOTED TO HAVE, ¿PERSISTENT CERVICAL AND OCCIPITAL PAIN.¿ PRE- OPERATIVE IMAGING SHOWED, ¿PRESENCE OF PSEUDARTHRITIS WITH LUCENCY AROUND HER SCREWS AND A PAUCITY OF INTERBODY SUPPORT." THIS REPORT CAPTURES THE FIRST OF FOUR REFLEX HYBRID BONE SCREWS. REPORTS HAVE BEEN FILED SEPARATELY FOR ASSOCIATED DEVICES.

  Patient problems: Neck Pain; Ptosis

  MAUDE report 8952405 ↗
• InjuryAug 30, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  A PATIENT REPORTED THAT A REVISION SURGERY OCCURRED SOMETIME IN 2010, POSSIBLY TO ADDRESS, ¿SOME LOOSE OR FRACTURED SCREWS,¿ (PATIENT WAS UNCLEAR ON THE EVENT). FOLLOW-UP INFORMATION, INCLUDING PREOPERATIVE AND INTRAOPERATIVE NOTES, DOES NOT INDICATE THE PRESENCE OF LOOSE OR FRACTURED SCREWS. THE PHYSICIAN¿S NOTES (DATED (B)(6) 2007) INDICATE THE PATIENT EXPERIENCED HEADACHES, A DECREASE OF SENSATION ON THE LEFT SIDE ALONG WITH, ¿MODERATE LEFT SIDE PTOSIS,¿ AND, ¿LEFT-SIDED HORNER¿S SYNDROME¿. THE PHYSICIAN ADDITIONALLY NOTED, ¿RIGHT PUPIL 2.5 MM DOWN TO 2 MM WITH LIGHT," AND, "LEFT PUPIL 2 MM DOWN TO 1.5 MM WITH LIGHT.¿ THE OPERATIVE REPORT (DATED (B)(6) 2010) STATES THAT THE PATIENT WAS NOTED TO HAVE, ¿PERSISTENT CERVICAL AND OCCIPITAL PAIN.¿ PRE OPERATIVE IMAGING SHOWED, ¿PRESENCE OF PSEUDOARTHROSIS WITH LUCENCY AROUND HER SCREWS AND A PAUCITY OF INTERBODY SUPPORT."

  Patient problems: Neck Pain; Ptosis

  MAUDE report 8952284 ↗
• InjuryApr 15, 2019Device Dislodged or Dislocated; Unintended Movement; Appropriate Device Problem Term/Code Not Available; Unintended Movement

  IN (B)(6) 2018 THE DEVICE WAS IMPLANTED. ON REVIEW OF X-RAY DURING A POST-OPERATIVE CHECK-UP, THE PHYSICIAN NOTED THAT A LOCKING SCREW WAS "OUT OF ITS PLACE." THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019 DURING WHICH THE DISLOCATED LOCKING SCREW WAS REMOVED. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: Injury; No Known Impact Or Consequence To Patient

  MAUDE report 8516816 ↗
• MalfunctionFeb 10, 2016Material Deformation; Material Integrity Problem; Break; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT THE SCREW DAMAGED DURING THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5429024 ↗