LUXOR 48250240Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327266177), received between Sep 5, 2017 and Feb 22, 2021 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2021Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT A LUXOR ARM POST 'WOULD NOT CLAMP ONTO THE BED RAILING TIGHTLY ENOUGH' OUTSIDE THE OPERATING ROOM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11362630 ↗
• MalfunctionJul 23, 2020Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE 'TIGHTENING BAR COMPLETELY FELL OUT OF THE HINGE JOINT' ON A LUXOR ARM POST INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY USING AN ALTERNATIVE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10316986 ↗
• MalfunctionJul 23, 2020Detachment of Device or Device Component; Mechanical Jam; Detachment of Device or Device Component; Mechanical Jam

  IT WAS REPORTED THAT DURING PRE-OPERATIVE PREPARATION A LUXOR ARM POST 'WILL NOT TIGHTEN DOWN TO HOLD THE RETRACTOR ARM'. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. AN ALTERNATIVE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Patient Involvement

  MAUDE report 10316849 ↗
• MalfunctionMar 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A LUXOR ARM POST SECURING MECHANISM DISSENGAGED INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9780257 ↗
• MalfunctionJul 19, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PIN IN THE ARM HAS FALLEN OUT WHEN TIGHTENING TO THE BED. NO ADVERSE CONSEQUENCES TO THE PATIENT HAS BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7703742 ↗
• MalfunctionApr 24, 2018Device Dislodged or Dislocated; Component Missing; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ARM POST WAS NO ATTACHING TO THE BED DURING A PROCEDURE. ANOTHER PAN WITH A BACK UP ARM POST WAS USED TO COMPLETE THE PROCEDURE. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7455570 ↗
• MalfunctionFeb 16, 2018Mechanical Problem; Device Slipped; Mechanical Problem

  IT WAS REPORTED THAT THE RETRACTOR ARM POST WOULD NOT TIGHTEN TO THE BED IN THE OPERATING ROOM. A BACK UP ARM POST WAS ALSO SLIPPING WHEN TRYING TO TIGHTEN AND EVENTUALLY FAILED AS WELL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRD POST. THERE WAS NO DELAY IN SURGERY OR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7278671 ↗
• MalfunctionFeb 16, 2018Accessory Incompatible; Mechanical Problem; Device Slipped; Mechanical Problem

  IT WAS REPORTED THAT THE RETRACTOR ARM POST WOULD NOT TIGHTEN TO THE BED IN THE OPERATING ROOM. A BACK UP ARM POST WAS ALSO SLIPPING WHEN TRYING TO TIGHTEN AND EVENTUALLY FAILED AS WELL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRD POST. THERE WAS NO DELAY IN SURGERY OR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7278058 ↗
• MalfunctionNov 15, 2017Break

  IT WAS REPORTED THAT THE POST FOR TUBES BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7033254 ↗
• MalfunctionNov 15, 2017Break; Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE POST FOR TUBES BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7033251 ↗
• MalfunctionSep 5, 2017Mechanical Problem; Loose or Intermittent Connection; Mechanical Problem

  IT WAS REPORTED THAT; DURING SURGERY WHEN USING THE DECOMPRESSION TUBE POST THAT COMES IN THE SET, WHEN TIGHTENING THE PIN IT KEPT GOING THROUGH THE SPRING OF THE LOCKING MECHANISM. IT ULTIMATELY WOULDN'T TIGHTEN THE POST. TRIED A SECOND POST AND THE SAME ISSUE OCCURRED. BOTH WERE USED 50-100X EACH. THE INSTRUMENTS WEREN'T OBSERVED PRIOR TO THE SURGERY BECAUSE THEY BOTH WERE USED PREVIOUSLY SUCCESSFULLY THE DAY BEFORE THE SURGERY. NO LUBRICATION PERFORMED ON THE INSTRUMENTS BECAUSE IT WAS NOT NEEDED. THE SURGEON WAS PERFORMING AN MIS DISCECTOMY AND HAD TO OPEN THE INCISION TO USE OTHER INSTRUMENTATION TO COMPLETE THE PROCEDURE.

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

  MAUDE report 6843657 ↗
• InjurySep 5, 2017Mechanical Problem; Mechanical Problem; Device Operates Differently Than Expected

  IT WAS REPORTED THAT; DURING SURGERY WHEN USING THE DECOMPRESSION TUBE POST THAT COMES IN THE SET, WHEN TIGHTENING THE PIN IT KEPT GOING THROUGH THE SPRING OF THE LOCKING MECHANISM. IT ULTIMATELY WOULDN'T TIGHTEN THE POST. TRIED A SECOND POST AND THE SAME ISSUE OCCURRED. BOTH WERE USED 50-100X EACH. THE INSTRUMENTS WEREN'T OBSERVED PRIOR TO THE SURGERY BECAUSE THEY BOTH WERE USED PREVIOUSLY SUCCESSFULLY THE DAY BEFORE THE SURGERY. NO LUBRICATION PERFORMED ON THE INSTRUMENTS BECAUSE IT WAS NOT NEEDED. THE SURGEON WAS PERFORMING AN MIS DISCECTOMY AND HAD TO OPEN THE INCISION TO USE OTHER INSTRUMENTATION TO COMPLETE THE PROCEDURE.

  Patient problems: Failure of Implant; Injury

  MAUDE report 6843611 ↗