NA 72200670Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010578112), received between Sep 2, 2019 and Mar 22, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (4 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.

• MalfunctionMar 22, 2022Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY PROCEDURE, AT THE FINAL CLOSING, THE BED COLLAPSED AND SUDDENLY FELL. THE DOCTORS GRABBED THE PATIENT BEFORE TOUCHING THE FLOOR. PART OF THE BED HAD BROKEN, AND PART BENT. THE CLAMP THAT WAS CONNECTED TO THE BED RAIL WAS BROKEN AND THE SCREW THAT CONNECTED THE LEG TO THE BED BECAME TWISTED. NO DELAY WAS REPORTED AND IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13847476 ↗
• MalfunctionSep 4, 2019Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING SURGERY, THE PATIENT'S POSITIONING DEVICE JAW BROKE CAUSING A LOSS OF TRACTION. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. NO SIGNIFICANT DELAY OR PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8963076 ↗
• MalfunctionSep 4, 2019Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING SURGERY, THE PATIENT'S POSITIONING DEVICE JAW BROKE CAUSING A LOSS OF TRACTION. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. NO SIGNIFICANT DELAY OR PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8963062 ↗
• MalfunctionSep 2, 2019Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A HIP ASK THE DEVICE'S JAW BROKE CAUSING A LOSS OF TRACTION. NO INSTRUMENTS WERE INSIDE THE PATIENT WHEN THE EVENT OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. NO SIGNIFICANT DELAY OR PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8954002 ↗
• MalfunctionSep 2, 2019Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC HIP SURGERY, THE PATIENT'S POSITIONING DEVICE JAW BROKE CAUSING A LOSS OF TRACTION. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. NO SIGNIFICANT DELAY OR PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8953998 ↗