N/A 9734856Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169045040), received between Sep 30, 2016 and Jul 9, 2020 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2020Degraded; Degraded

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE DRIVER WAS WORN. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 10254473 ↗
• MalfunctionJul 5, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. THE ISSUE OCCURRED INTRAOPERATIVELY AND DELAYED THE SURGERY BY LESS THAN ONE HOUR. IT WAS REPORTED THAT THE PATIENT HAD PRIOR HARDWARE IN FROM L1-S1 AND NEEDED TO BE DECOMPRESSED AND SAGITTALLY REALIGNED. DURING THE SURGERY, THE SOLERA DRIVER BROKE WHILE TRYING TO PLACE A SCREW IN VERY SCLEROTIC BONE. THE SITE WAS ABLE TO REMOVE THE DRIVER AND THE BROKEN PIECE FROM THE WOUND, FIND ANOTHER NAVIGATED DRIVER, AND PROPERLY PLACE THE SCREW WITHOUT HARM TO PATIENT. NO BROKEN PIECES REMAINED IN THE PATIENT. IT WAS ALSO REPORTED THAT THE SOLERA SCREW DRIVER WAS USED TO GET THE OLD SCREWS OUT BUT THE BONE WAS SCLEROTIC AND THE DRIVER BROKE. THE BROKEN PIECE WAS RETRIEVED SUCCESSFULLY FROM THE WOUND AND NOTHING REMAINED IN THE PATIENT. THE SURGERY WAS COMPLETED WITH NAVIGATION AND THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8764750 ↗
• MalfunctionOct 25, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A POSTERIOR LUMBAR INTERBODY FUSION (PLIF). IT WAS REPORTED THAT DURING THE INSERTION OF THE SCREW INTO S1, THE DRIVER SLIPPED AND BROKE THE TIP OFF INTO THE SHANK OF THE SOLERA 4.75-7.5 MM SCREW. THE HEALTH CARE PROFESSIONAL (HCP) WAS ABLE TO REMOVE THE FRAGMENT OF THE DRIVER FROM THE PATIENT CAUSING NO HARM. THE HCP DID NOT TAP THE BONE TO SIZE AND MAY THIS MAY HAVE CONTRIBUTED TO THE FORCE REQUIRED TO INSERT THE SCREW. ON THE OTHER SCREWS THE HCP DECIDED TO TAP ON THE DRIVER. NAVIGATION WAS ABORTED ON THE LAST SCREW. THERE WAS NO DELAY TO THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME. NO FRAGMENTS WERE LEFT IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8005941 ↗
• MalfunctionSep 7, 2017Bent; Material Deformation; Bent; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION PROCEDURE THE TIP OF THE SOLERA DRIVER WAS BENT. SITE CONTINUED THE USE OF INSTRUMENT AND COMPLETED THE PROCEDURE. MEDTRONIC REPRESENTATIVE SUSPECTED THAT THE REPORTED ISSUE OCCURRED WHILE THE INSTRUMENT WAS IN THE PATIENT ANATOMY. THE PROCEDURE WAS COMPLETED WITH THE USE OF NAVIGATION. THERE WAS NO DELAY TO THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6849770 ↗
• MalfunctionAug 30, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION, THE DRIVER BEING USED BECAME DAMAGED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6832419 ↗
• MalfunctionMay 4, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION, THE SCREW DRIVER WAS WORN AND WOULD NOT GRIP THE SCREW HEAD TIGHTLY. THE SITE ELECTED TO CONTINUE WITH ANOTHER DRIVER. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6544266 ↗
• MalfunctionMar 30, 2017Device Operates Differently Than Expected; Material Deformation; Device Operates Differently Than Expected; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION, THE SCREW DRIVER FOR THE PROCEDURE BECAME SHEARED. THE SHEARING WAS REPORTED TO HAVE BEEN CAUSED BY THE BONE DENSITY OF THE PATIENT AND THE TORQUE REQUIRED TO INSERT THE SCREW. THE SITE ELECTED TO COMPLETE THE PROCEDURE WITH A SEPARATE INSTRUMENT. 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. TWO SCREWDRIVERS WERE REPORTED TO BE DAMAGED DURING THE PROCEDURE, THE FIRST IS DOCUMENTED UNDER FILING NUMBER 1723170-2017-01415.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6447435 ↗
• MalfunctionMar 30, 2017Device Operates Differently Than Expected; Material Twisted/Bent; Device Operates Differently Than Expected; Material Twisted/Bent

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION, THE TIP OF THE SCREWDRIVER TWISTED DUE TO THE PATIENT'S BONE DENSITY AND TORQUE REQUIRED FOR SCREW INSERTION. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6447418 ↗
• MalfunctionSep 30, 2016Device Inoperable; Material Deformation; Device Inoperable; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT THEIR SOLERA SCREWDRIVER WAS DEFECTIVE AND UNUSABLE. THE HEAD OF THE DRIVER IS WORN AND THE DRIVER TURNS AROUND WITHOUT GRIPPING THE IMPLANT. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 5992060 ↗