Superion Interspinous Spacer 14mmRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884662000284), received between Sep 13, 2017 and Jun 20, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUPERION INDIRECT DECOMPRESSION SPACER (SPACER) PATIENT DEVELOPED PAIN AT THE SURGICAL SITE AND DOWN LEG. THE PHYSICIAN DETERMINED FROM IMAGING THAT THE IMPLANT MAY HAVE BEEN OVERSIZED AND DECIDED TO REPLACE THE DEVICE WITH A REDUCED SIZE. THE PATIENT WAS DOING FINE POST-OPERATIVELY. THE EXPLANTED SPACER AS DISPOSED OF BY THE MEDICAL FACILITY.

  Patient problems: Implant Pain; Pain

  MAUDE report 19579247 ↗
• InjuryJan 29, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED MIGRATION OF THE IMPLANT AND RETURN OF THE PREEXISTING PAIN. RADIOGRAPHY CONFIRMED A SLIGHT MIGRATION OF THE DEVICE TO BE A/P, ANTERIOR-POSTERIOR DISPLACEMENT. DURING THE REVISION PROCEDURE, THE PHYSICIAN ATTEMPTED MULTIPLE TIMES TO LOOSEN THE IMPLANT USING THE DRIVER, ON THE FINAL ATTEMPT IT WAS NOTED THE PRONGS ON THE DRIVER WERE BENT. A NEW DRIVER WAS USED TO SUCCESSFULLY LOOSEN THE IMPLANT; HOWEVER, THE PHYSICIAN WAS UNABLE TO REMOVE THE IMPLANT. THE IMPLANT WAS RETIGHTENED, AND THE CASE ABORTED. THE PATIENT WAS REFERRED TO A SPINE SURGEON TO EXPLANT THE MIGRATED IMPLANT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13390050 ↗
• InjuryJul 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SEVERAL DAYS AFTER THE PATIENT UNDERWENT A SPACER EXPLANT PROCEDURE (MFR REPORT NUMBER 3006630150-2021-03815), THE PATIENT DEVELOPED A PROCEDURE RELATED INFECTION AND EXPERIENCED PAIN, REDNESS, AND MINIMAL PURULENT DISCHARGE AT THE LOWER LUMBAR INCISION SITE. THE PATIENT WAS ADMINISTERED CEPHALEXIN AND THE EVENT RESOLVED.

  Patient problems: Bacterial Infection; Pain

  MAUDE report 12185787 ↗
• InjuryJul 16, 2021Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Migration; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INCREASE OF ACUTE AXIAL AND RADICULAR LOW BACK PAIN. THE X-RAY TAKEN REVEALED THAT THE CAM LOBE WAS BROKEN. THE INFERIOR ARM OF THE SPACER WAS DISLOCATED AND DISLODGED POSTERIOR. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE ALL THE PIECES OF THE SPACER WERE EXPLANTED. THE PATIENT FELT A DRAMATIC IMPROVEMENT POST-OPERATIVELY. THE DEVICE WILL NOT BE RETURNED.

  Patient problems: Pain

  MAUDE report 12185265 ↗
• InjurySep 13, 2017Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  MANUFACTURER'S CASE COVERAGE SPECIALIST FORWARDED X-RAY IMAGES SUGGESTING "DISLODGEMENT OF L3-4 SUPERION." DEVICE REMAINS IN SITU.

  Patient problems: Bone Fracture(s); Tissue Damage

  MAUDE report 6863372 ↗