LUXOR 48250030Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327266061), received between May 25, 2016 and May 25, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2016Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT, " THE SURGEON PUT 4 PEDICLE SCREWS AND ONE CAGE. WHEN OPENING THE BOXES OF THE DEVICE, THE MEDIAL ARM OF THE SPREADER WAS BROKEN IN THE PISTON CENTRAL LEVEL WHICH UNABLE THE FULL WITHDRAWAL OF THE BLADE. WHEN USING THE SPREADER, FACING THE IMPOSSIBILITY TO SEPARATE THE TWO BLADES CLIPPED BASED ON THE RETRACTOR, THE SURGEON HAD TO REMOVE THE PATIENT'S STENT, REMOVE THE SILICONE BLADE, THEN MAKE SO THAT THE SCREW SERVING TO DEVIATE IS ENGAGED AGAIN WITH ITS BASE TO ACTUATE THE WEDGE MECHANISM. THIS MANUALLY SEPARATING THE BLADES AS HE INSISTED THAT THE SCREW IS ENGAGED WITH THE BASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5679944 ↗