Medtronic Reusable Instruments 9561523Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00721902974809), received between May 12, 2021 and May 12, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Align” (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 12, 2021Failure to Align; Failure to Align

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING PRODUCT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE BED RAIL CLAMP AND FLEX ARM WOULD NOT HOLD POSITION. THE EVENT WAS INTRA-OP. THE PATIENT WAS ASLEEP, DRAPED AND INCISION WAS MADE. THE CLAMP AND THE FLEX ARM WOULD NOT HOLD POSITION ONCE THE RETRACTOR WAS ATTACHED. THERE IS NO FRAGMENT LEFT IN THE PATIENT. THE PATIENT WAS ON ANESTHESIA DURING A 5 MINUTE WAIT TO GET A DIFFERENT CLAMP AND FLEX ARM IN THE ROOM AND ATTACHED TO THE SURGICAL TABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11811285 ↗