X-STOP® Interspinous Spacer 1-3212 (UDI 00643169132825)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169132825), received between Nov 13, 2017 and Sep 30, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration or Expulsion 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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING USE, STENOSIS WAS DEVELOPED IN THE PATIENT. SO, REVISION SURGERY WAS PERFORMED TO REMOVE X-STOP INSTRUMENT. THE X-STOP INSTRUMENT WAS REMOVED AND LAMINECTOMY WAS PERFORMED. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. PATIENT WAS NOT HOSPITALIZED FOR PROLONG. PATIENT ISSUE IS RESOLVED. LEVELS IMPLANTED IN INITIAL SURGERY- L4/5. RECEIVED UPDATED INFORMATION THAT PATIENT RECOVERED AFTER THE REVISION SURGERY. REPORTED THERE IS NO MALFUNCTION OF THE PRODUCT. PATIENT OUTCOME: NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED.

  Patient problems: Stenosis

  MAUDE report 10606501 ↗
• InjuryNov 13, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR SPINAL CANAL STENOSIS AND WAS ENROLLED IN POST MARKET STUDY. POST-OP, THE LOOSENING OF IMPLANT WAS REPORTED AT L4-L5. A REVISION SURGERY WAS PERFORMED FOR THE REMOVAL AND RE-INSERTION OF ANOTHER IMPLANT. THE PATIENT WAS WITHDRAWN FROM STUDY ON (B)(6) BECAUSE SURGICAL TREATMENT ACCOMPANIED BY REMOVAL OF THIS PRODUCT WAS NECESSARY, AND IT BECAME DIFFICULT TO CONTINUE TO INVESTIGATE THE SAFETY AND EFFICACY OF THIS PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient; Swelling

  MAUDE report 7026578 ↗

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 · Terminated
  X-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 · Terminated
  St. 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