Palisade Pedicular Fixation System 10-10-60-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M7406704110), received between Oct 11, 2016 and Oct 11, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 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.

• MalfunctionOct 11, 2016Device Slipped; Device Dislodged or Dislocated; Device Slipped; Device Dislodged or Dislocated

  PRIOR TO THE INITIAL SURGICAL PROCEDURE, THE PATIENT WAS POSITIONED ON A JACKSON TABLE. THE PATIENT RECEIVED A MULTI-LEVEL SPINAL CONSTRUCT WITH PLACEMENT OF INTERVERTEBRAL BODY FUSION DEVICES ON (B)(6) 2016. DURING PLACEMENT OF THE RODS, THE PHYSICIAN WAS UNABLE TO ADVANCE THE RODS FULLY BEYOND THE TULIP HEADS DUE TO INTERFERENCE FROM EITHER SOFT TISSUE OR BONE. MULTIPLE RADIOGRAPHIC IMAGES OF THE FINAL CONSTRUCT WERE TAKEN AT DIFFERENT ANGLES AND THE PHYSICIAN FELT COMFORTABLE WITH THE PURCHASE/INTERFACE OF THE RODS AND SET SCREWS. FOLLOWING THE SURGICAL PROCEDURE, THE PATIENT REPORTED HEARING A "POP" IN HIS BACK WHEN HE WAS ROLLING OVER IN BED. FOLLOW-UP RADIOGRAPHIC IMAGING REVEALED THAT BOTH RODS HAD SLIPPED FROM THE TULIP HEADS AT THE CAUDAL END OF THE CONSTRUCT WHILE THE SET SCREWS REMAINED IN PLACE. THE PHYSICIAN INTENDS TO PERFORM A SECOND SURGICAL PROCEDURE.

  Patient problems: No Information

  MAUDE report 6017495 ↗