Superion Interspinous Spacer 12mmRecalls & reported problems
Vertiflex, Inc. · Superion Interspinous Spacer, 12mm · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884662000260), received between Aug 12, 2021 and Sep 7, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS NO LONGER RECEIVING RELIEF FROM THE SUPERION INDIRECT DECOMPRESSION SPACER (SPACER). A FLOUROSCOPY SHOWED THAT THE DEVICE WAS WELL PLACED AND THERE WAS NO EVIDENCE OF DEVICE FAILURE OR DAMAGE. THE PHYSICIAN PROCEEDED WITH EXPLANT. DURING THE EXPLANT, THE DEVICE WAS UNDEPLOYED BUT DUE TO BONY OVERGROWTH THE SPACER COULD NOT BE REMOVED. THE SPACER WAS REDEPLOYED AND LEFT IN PLACE AND THE INCISION WAS CLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15374377 ↗InjuryAug 12, 2021Migration; Migration
IT WAS REPORTED THAT OVER A YEAR AFTER IMPLANTATION OF THE SUPERION INDIRECT DECOMPRESSION SPACER, THE PATIENT REPORTED THAT HER ORIGINAL SYMPTOMS RETURNED. THE PATIENT HAD AN X-RAY THAT SHOWED THE SPACER HAD MIGRATED. THE PHYSICIAN ATTEMPTED TO PERFORM AN EXPLANT HOWEVER DURING THE PROCEDURE, THE DEVICE COULD NOT BE REMOVED. THE PHYSICIAN WAS UNABLE TO UNDEPLOY THE SPACER AND INSTEAD OPTED TO TAP THE SPACER DOWN FURTHER IN THE SPINE. THE REVISION WAS SUCCESSFUL AND THE PATIENT RECOVERED. NOTHING WAS EXPLANTED OR IMPLANTED DURING THIS PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12312057 ↗
Other Prosthesis, Spinous Process Spacer/Plate devices
- Superion™ 101-9812Boston Scientific Neuromodulation Corporation · Prosthesis, Spinous Process Spacer/Plate2 recalls810 reports
- Superion™ 101-9810Boston Scientific Neuromodulation Corporation · Prosthesis, Spinous Process Spacer/Plate1 recall356 reports
- Superion™ 101-9814Boston Scientific Neuromodulation Corporation · Prosthesis, Spinous Process Spacer/Plate2 recalls295 reports
- Superion™ SUI 102-9800Boston Scientific Neuromodulation Corporation · Prosthesis, Spinous Process Spacer/Plate2 recalls123 reports
- Superion™ 101-9808Boston Scientific Neuromodulation Corporation · Prosthesis, Spinous Process Spacer/Plate2 recalls4 reports
- Vertiflex™ VIP 140-9800Boston Scientific Neuromodulation Corporation · Prosthesis, Spinous Process Spacer/Plate1 recall23 reports
- Superion™ 101-9816Boston Scientific Neuromodulation Corporation · Prosthesis, Spinous Process Spacer/Plate1 recall23 reports
- Superion Interspinous Spacer 14mmVertiflex, Inc. · Prosthesis, Spinous Process Spacer/Plate5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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