REFLEX HYBRID 48511905RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327276831), received between Sep 13, 2016 and Apr 11, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 18, 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.

• MalfunctionApr 11, 2022Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT A REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT FRACTURED DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14078890 ↗
• MalfunctionFeb 22, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT A REFLEX-HYBRID FIXATION PIN AND SCREW EXTRACTOR INNER SHAFT WERE OBSERVED TO BE BENT OUTSIDE THE OR. THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED. THIS REPORT WILL CAPTURE THE INNER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13577967 ↗
• MalfunctionJan 17, 2018Break; Detachment Of Device Component; Fracture; Fracture

  IT WAS REPORTED THAT THE DRAW ROD OF THE SCREW EXTRACTOR TIP BROKE OFF AND SCREW DURING EXTRACTION. UPDATE ADDITIONAL INFORMATION FROM REP CONFIRMED THAT THE REVISION SURGERY WAS PERFORMED FOR EXTENSION. "THIS WAS A REVISION SURGERY, ACDF WAS BEING EXTENDED. PATIENT NEEDED TO FUSE IN AN ADDITIONAL LEVEL. THE SCREW WAS NOT BROKEN, IT WAS INTACT."

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7200075 ↗
• MalfunctionSep 13, 2016Detachment Of Device Component; Fracture; Fracture

  IT WAS REPORTED THAT ATER FINAL X-RAYS ON A 3-LEVEL ACDF (C3-6) IT WAS DETERMINED ONE LEVEL OF SCREWS WAS NOT IN VERTEBRAL BODY BUT IN DISC SPACE. THE SURGEON WAS COMFORTABLE THAT REMOVING SCREWS AND NOT REPLACING WOULD NOT COMPROMISE FUSION. THE 3-PIECE SCREW EXTRACTOR TOOL WAS ASSEMBLED AND USED. FIRST SCREW WAS REMOVED. UPON ATTEMPT OF SECOND SCREW REMOVAL THE TIP OF THE INNER SHAFT SCREW EXTRACTOR SHEARED OFF WITHIN THE CRUCIFORM OF THE BONE SCREW. THE SURGEON ATTEMPTED TO REMOVE WITH OTHER TOOLS BUT BECAUSE THE SHAFT WAS IN THE CRUCIFORM HE DECIDED TO LEAVE IT IN AS IT POSED NO COMPROMISE TO FUSION OR INSTRUMENTATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5945712 ↗