Superion Driver N/ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884662000123), received between Oct 22, 2018 and Nov 1, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (2 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. How this data works · Data updated Oct 13, 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 1, 2018Difficult or Delayed Positioning; Material Fragmentation; Difficult or Delayed Positioning; Material Fragmentation

  DURING ATTEMPTS TO PLACE A SUPERION IDS AT L3/L4, THE DISTAL TIP OF THE MANUAL DRIVER INSTRUMENT BROKE OFF. THE FRAGMENT WAS FIRMLY LODGED IN THE PROXIMAL END OF THE IMPLANT, AND RESISTED THE PHYSICIAN'S EFFORTS TO EXTRACT IT. AS IT WAS FIRMLY ATTACHED TO THE IMPLANT, AND THE IMPLANT WAS CORRECTLY PLACED, THE PHYSICIAN ELECTED TO LEAVE IT IN PLACE AND CLOSE. THE COMPANY REPRESENTATIVE WHO WAS OBSERVING THE CASE REPORTS THAT THE INTERSPINOUS SPACE INTO WHICH THE IMPLANT WAS BEING PLACED WAS "VERY TIGHT" SUCH THAT SIGNIFICANT RESISTANCE TO IMPLANT DEPLOYMENT WAS EXPERIENCED. HE SUGGESTED THAT THE PHYSICIAN APPLIED EXCESSIVE TORQUE TO THE DRIVER TO COMPLETE IMPLANT PLACEMENT, WHICH MAY HAVE EXCEEDED THE STRENGTH OF THE DRIVER, RESULTING IN THE FRACTURE OF THE DISTAL TIP.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 8029272 ↗
• MalfunctionOct 22, 2018Difficult or Delayed Positioning; Material Fragmentation; Difficult or Delayed Positioning; Material Fragmentation

  DURING ATTEMPTS TO PLACE A SUPERION IDS IMPLANT AT L4/L5, SIGNIFICANT RESISTANCE TO DEPLOYMENT WAS ENCOUNTERED. TO OVERCOME THIS RESISTANCE, EXCESSIVE TORQUE WAS APPLIED BY THE TREATING PHYSICIAN IN AN ATTEMPT TO DEPLOY THE IMPLANT, WITH THE RESULT THAT ONE (1) 10MM IMPLANT WAS BROKEN. THIS IMPLANT WAS SUCCESSFULLY REMOVED WITHOUT ISSUE, AND A SECOND IMPLANTATION ATTEMPTED. WHILE THIS IMPLANT WAS SUCCESSFULLY PLACED, ALBEIT AFTER THE PHYSICIAN USED A MALLET TO FINISH DEPLOYMENT, DURING DEPLOYMENT THE TIP OF THE MANUAL DRIVER INSTRUMENT FRACTURED. A PORTION OF THE FRACTURED TIP REMAINED FIRMLY ENGAGED WITHIN THE DISTAL END OF THE IMPLANT BODY, AND WAS ALLOWED BY THE PHYSICIAN TO REMAIN IN SITU. IT IS NOTABLE THAT THE PATIENT PRESENTED WITH BOTH ANKYLOSIS AND SIGNIFICANT SCOLIOSIS, WHICH ARE BOTH CONTRAINDICATED CONDITIONS, AND WOULD HAVE BEEN THE PROXIMATE CAUSE(S) OF THE RESISTANCE TO DEPLOYMENT ENCOUNTERED. SEVERAL UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO CONTACT THE TREATING PHYSICIAN TO DISCUSS THE RAMIFICATIONS OF THE DRIVER FRAGMENT LEFT IN SITU. WE WILL CONTINUE TO ATTEMPT TO FOLLOW UP WITH THE CLINICIAN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7991718 ↗