Superion Interspinous Spacer 16mmRecalls & reported problems
Vertiflex, Inc. · Superion Interspinous Spacer, 16mm · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884662000307), received between Oct 30, 2025 and Oct 30, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Open or Close” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Open or Close1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2025Difficult to Open or Close; Difficult to Open or Close
DEVICE ANALYSIS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED DAMAGE TO THE SUPERIOR CAM LOBE DRIVING TAB. THIS DAMAGE PREVENTED THE ACTUATOR MATING SURFACE FROM PROPERLY ENGAGING WITH THE TABS THAT DRIVE THE CAM LOBES, CAUSING THE SPACER TO FAIL FUNCTIONAL TESTING. THE OBSERVED DAMAGE ON THE SUPERIOR CAM LOBE DRIVING TAB WAS LIKELY DUE TO REPEATED DEPLOYMENT ATTEMPTS, WHICH JAMMED THE ACTUATOR AGAINST THE SUPERIOR CAM LOBES AND MADE IT DIFFICULT TO DEPLOY THE SUPERIOR LOBES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23433247 ↗
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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