X-STOP® Interspinous Spacer 1-3208 (UDI 00643169132849)Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 1-3208 US 8MM X-STOP PEEK · 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 00643169132849), received between Nov 9, 2017 and Nov 9, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Malposition of Device” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Malposition of Device1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 9, 2017Malposition of Device; Malposition of Device
PRE-OP DIAGNOSIS: LUMBAR SPINAL CANAL STENOSIS IT WAS REPORTED THAT ON THE PATIENT UNDERWENT UNSPECIFIED SURGERY AND LAMINECTOMY AT L3-L4 AND L4-L5 USING SPACER DUE TO LUMBAR SPINAL CANAL STENOSIS. POST-OP, PATIENT COMPLAINED OF STRONG BACK PAIN. ON (B)(6) 2014 AN IMAGE INSPECTION WAS CONDUCTED WHICH REVEALED THAT THE INTERSPINOUS EXPANSION HAD NOT BEEN MAINTAINED BECAUSE OF THE ABNORMAL POSITIONING OF THE IMPLANTS. PATIENT UNDERWENT REVISION SURGERY FOR REMOVAL OF THE IMPLANTS.
Patient problems: Pain
MAUDE report 7014369 ↗
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
- 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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