REFLEX HYBRID 48651116Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540534736), received between Jul 3, 2019 and Aug 30, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

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 3 most recent of 3 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 A ONE LEVEL REFLEX HYBRID PLATE. REPORTS HAVE BEEN FILED SEPARATELY FOR ASSOCIATED DEVICES.

  Patient problems: Neck Pain; Ptosis

  MAUDE report 8952717 ↗
• MalfunctionJul 5, 2019Mechanical Jam; Material Protrusion/Extrusion; Mechanical Jam

  IT WAS REPORTED THAT DURING C5/C6 FIXATION, THE LOCKING RING OF THE PLATE WAS VISIBLE BEFORE THE SCREW WAS IMPLANTED AND LOCKING COULD NOT BE CONFIRMED. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8765017 ↗
• MalfunctionJul 3, 2019Fracture; Fracture; Insufficient Device Problem Information

  STRYKER WAS INFORMED OF A POSSIBLE EVENT INVOLVING THIS DEVICE. ADDITIONAL DETAILS HAVE NOT YET BEEN MADE AVAILABLE. A SUPPLEMENTAL REPORT WILL BE FILED UPON RECEIPT OF ADDITIONAL INFORMATION. UPON FURTHER REVIEW, IT HAS BEEN DETERMINED THAT THIS IS A DUPLICATE OF REPORT 0009617544-2019-00085.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 8760941 ↗