Superion Interspinous Spacer 8mmRecalls & reported problems
Vertiflex, Inc. · Superion Interspinous Spacer, 8mm · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884662000222), received between Aug 14, 2018 and Aug 14, 2018 — classified as 1 injury.
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
Patient problems
- Bone Fracture(s)1
- Pain1
- Spinal Column Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PHYSICIAN REPORTS THAT A PATIENT HE IMPLANTED WITH THE SUPERION DEVICE CONTACTED HIM REGARDING ONSET OF ACUTE PAIN. PHYSICIAN EXAMINED THE PATIENT AND CONFIRMED A SPINOUS PROCESS FRACTURE. PATIENT REPORTS IT OCCURRED WHEN LINE DANCING. PHYSICIAN ADVISES HE WILL TREAT FOR PAIN ACUTELY AND FOLLOW PATIENT CLOSELY. SPINOUS PROCESS FRACTURES ARE A RECOGNIZED LOW-FREQUENCY RISK ASSOCIATED WITH THE SUBJECT DEVICE, AND LIKELIHOOD OF OCCURRENCE IS INCREASED IN THE PRESENCE OF CERTAIN KNOWN RISK FACTORS. IT IS NOT KNOWN WHETHER ANY SUCH RISK FACTOR(S) WAS (WERE) PRESENT IN THIS CASE.
Patient problems: Bone Fracture(s); Pain; Spinal Column Injury
MAUDE report 7782904 ↗
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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