N/A 9734715K (UDI 00643169540453)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169540453), received between Sep 22, 2016 and Nov 28, 2016 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Inoperable” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2016Unintended Movement; Unintended Movement

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE SURGEON NOTED THAT THE SCREW THAT HELD THEIR SPINOUS PROCESS TALL CLAMP AND THE SPINE REFERENCE FRAME TOGETHER WAS LOOSE. THIS DID NOT CAUSE ANY ISSUES, AND NO DELAY IN THERAPY. THE SURGEON OPTED TO CONTINUE AND COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6129940 ↗
• InjurySep 22, 2016Device Inoperable; Material Deformation; Device Inoperable; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, AT THE END OF A SPINE PROCEDURE, THE SURGEON COULD NOT REMOVE THE TALL SPINOUS PROCESS CLAMP FROM THE PATIENT. THE NUT USED TO TIGHTEN THE CLAMP WAS IMMOVABLE. THE SURGEON REMOVED THE PATIENT'S SPINOUS PROCESS IN ORDER TO RELEASE THE CLAMP. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO DELAY OF THERAPY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: Iatrogenic Source; No Consequences Or Impact To Patient; Spinal Column Injury; Tissue Damage

  MAUDE report 5970206 ↗