X-STOP® Interspinous Spacer 1-3208 (UDI 00613994598721)Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 1-3208 US 8MM X STOPPK · Class 3 · Implant
Data updated Oct 16, 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 00613994598721), received between Jun 6, 2017 and Jun 6, 2017 — classified as 1 injury.
2 other recalls cover devices cleared under the same FDA submission (P040001); they may or may not involve this specific model.
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Inadequate Pain Relief1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PRE-OP DIAGNOSIS: LUMBAR CANAL STENOSIS. PROCEDURE: SPINAL STABILIZATION LEVELS IMPLANTED: L3-L4 IT WAS REPORTED THAT, POST-OP, "ZCQ" SCORE WORSENED. THE PATIENT OCCASIONALLY HAD LOW BACK PAIN, AND ALSO HAD MENTAL PROBLEM.
Patient problems: Inadequate Pain Relief; No Code Available
MAUDE report 6613750 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P040001. One submission often covers many models, so check the product and lot details in each record.
- Z-1765-2008 · Jan 30, 2008 · TerminatedX-STOP Interspinous Process Decompression (lPD) System, (With Physician's Guide, P/N 16000789-01 (Ti device), P/N 16001013-01 (PEEK device); Catalog numbers for X-STOP Titanium Imp
- Z-1258-06 · Jun 6, 2006 · TerminatedSt. Francis Medical Technologies brand X STOP Interspinous Process Decompression (IPD) System, 14 mm X STOP implants in peel pouch, Catalog #1-2210; The X STOP consists of a main b
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
- Superion™ 101-9816Boston Scientific Neuromodulation Corporation · Prosthesis, Spinous Process Spacer/Plate1 recall23 reports
- Vertiflex™ VIP 140-9800Boston Scientific Neuromodulation Corporation · Prosthesis, Spinous Process Spacer/Plate1 recall23 reports
- X-STOP® Interspinous Spacer 1-3210Medtronic Sofamor Danek, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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