N/A 9735129Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00643169308879), received between Nov 29, 2016 and Dec 10, 2018 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THERE WERE SOME INSTRUMENTS THAT WERE DAMAGED AND NEED TO BE REPLACED. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8147692 ↗
• MalfunctionSep 4, 2018Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SCREW TO TIGHTEN THE SPINE CLAMP WAS STARTING TO STRIP. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 7841481 ↗
• MalfunctionApr 3, 2018Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SCREW ON THE SPINE CLAMP WAS STRIPPED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7393976 ↗
• MalfunctionMar 1, 2018Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION PROCEDURE THE SCREW FIXATION ON THE SPINE CLAMP COULD NOT BE PROPERLY FIXED AT THE END OF THE SURGERY WHEN THE SURGEON WAS REMOVING THE CLAMP. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE AND NO IMPACT ON THE PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7305843 ↗
• MalfunctionJul 13, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION PROCEDURE, THE SPINE CLAMP SCREW HEAD WAS WORN. THE SURGERY WAS COMPLETED WITH THE USE OF ANOTHER CLAMP. THERE WAS A DELAY OF LESS THAN 1 HOUR. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6711370 ↗
• MalfunctionJun 15, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SPINE CLAMP WAS DAMAGED. IT WAS REPORTED THAT THE FIXATOR WAS DAMAGED AND FOUND DURING TRAINING. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6645000 ↗
• MalfunctionMay 23, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SCREW FOR THE SPINE CLAMP WAS STRIPPED AND COULD NOT BE ADJUSTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 6586049 ↗
• MalfunctionMay 3, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SPINE CLAMP WAS DAMAGED. THE DAMAGE WAS REPORTED TO BE DUE TO A DAMAGED SCREW ON THE CLAMP. THE REPORTED ISSUE WAS DISCOVERED IN STERILIZATION. 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 6540275 ↗
• MalfunctionMay 2, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SCREW ON THE SPINE CLAMP WAS STRIPPED. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 6536685 ↗
• MalfunctionMar 15, 2017Mechanical Problem; Mechanical Problem

  A SITE REPRESENTATIVE REPORTED THAT THE SPINOUS PROCESS CLAMP WAS DAMAGED. NO PATIENT WAS PRESENT DURING THE TIME OF THE REPORTED INCIDENT.

  Patient problems: No Patient Involvement

  MAUDE report 6406022 ↗
• MalfunctionJan 27, 2017Material Deformation; Unintended Movement; Material Deformation; Unintended Movement

  A MEDTRONIC REPRESENTATIVE RECEIVED A REPORT FROM THAT WHILE IN A SPINE PROCEDURE, THE SITE'S SPINE CLAMP WAS DAMAGED AND NO LONGER WORKS PROPERLY. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. A SECOND CLAMP WAS USED TO CONTINUE THE PROCEDURE TO COMPLETION. DELAY IN THERAPY WAS LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6283529 ↗
• MalfunctionNov 29, 2016Unintended Movement; Unintended Movement

  A MEDTRONIC REPRESENTATIVE RECEIVED A REPORT FROM A SITE THAT THEIR SPINE CLAMP WAS DAMAGED AND THE SCREW WAS STRIPPED. 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 6132786 ↗