N/A 9735278 (UDI 00643169340657)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169340657), received between Apr 21, 2017 and Jun 19, 2019 — classified as 3 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE TIP OF THE SCREW DRIVER BROKE OFF INTO THE SCREW HEAD. THE SURGEON WAS NOT ABLE TO REMOVE THE BROKEN PIECE AND DECIDED TO LEAVE IT IN AS THE ROD AND BOLT RETAINED IT. THE PROCEDURE WAS COMPLETED USING THE NAVIGATION SYSTEM AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR DUE TO THIS ISSUE. IT WAS SUSPECTED THAT APPLYING TOO MUCH FORCE/TORQUE WAS THE PROBABLE CAUSE OF THE BROKEN TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8713759 ↗
• MalfunctionJun 6, 2018Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED A SOLERA DRIVER TIP BROKE OFF DURING SURGERY. THE TIP OF DRIVER WAS LEFT IN THE SCREW HEAD. THE PROCEDURE WAS COMPLETED WITH THE USE OF NAVIGATION. THERE WAS NO REPORTED IMPACT TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7574390 ↗
• MalfunctionApr 21, 2017Device Operates Differently Than Expected; Material Deformation; Device Operates Differently Than Expected; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A SPINAL FUSION, THE TIP OF THE DRIVER WAS BROKEN. NO DETAILS WERE PROVIDED IN THE TYPE OF DAMAGED. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6510987 ↗