X-STOP® Interspinous Spacer 1-3210Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169132832), received between Apr 21, 2017 and Jun 8, 2018 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  LEVELS IMPLANTED: L4-L5 FOLLOWINGS WERE REPORTED VIA A CLINICAL STUDY: DATE HOSPITALIZED, SURGERY DATE, DATE DISCHARGED: (B)(6) 2013, COMMENTS IN CASE FOR THE PATIENT IS STILL HOSPITALIZED, OR DISCHARGE OF THE PATIENT WAS DELAYED: THERE IS NO HOSPITALIZATION/DISCHARGE FROM THE HOSPITAL DUE TO A DAY SURGERY. NAME OF ADVERSE EVENTS/MALFUNCTION: DISLOCATION OF THE IMPLANT. CAGE 10MM, CAUSALITY RELATIONSHIP BETWEEN THE EVENT AND COULD NOT BE RULED OUT. SEVERITY: SERIOUS. ADDITIONAL SURGERY: REMOVAL OF IMPLANT AND LAMINECTOMY. OTHER ADDITIONAL TREATMENT: NONE. OUTCOME DATE: (B)(6) 2015. OUTCOME: REMISSION. DETAILS OF THE ADVERSE EVENT OR NONCONFORMITY: PREOPERATIVE EXAMINATION WAS PERFORMED ON (B)(6) 2014. ON (B)(6) 2014, IMPLANT WAS REMOVED, AND LAMINECTOMY WAS PERFORMED. REHABILITATION WAS PERFORMED AT OTHER HOSPITAL AFTER DISCHARGE. LAST VISIT TO OUR HOSPITAL WAS ON (B)(6) 2015. COMMENTS FOR THE ADVERSE EVENT OR NONCONFORMITY: PREOPERATIVE EXAMINATION WAS PERFORMED ON (B)(6) 2014. ON (B)(6) 2014, IMPLANT WAS REMOVED, AND LAMINECTOMY WAS PERFORMED. REHABILITATION WAS PERFORMED AT OTHER HOSPITAL AFTER DISCHARGE. LAST VISIT TO OUR HOSPITAL WAS ON (B)(6) 2015. TYPE OF END/WITHDRAWAL: WIT

  Patient problems: Pain

  MAUDE report 7581770 ↗
• InjuryJun 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL STABILIZATION SURGERY DUE TO LUMBAR CANAL STENOSIS, IN WHICH THE IMPLANTS WAS USED. POST-OPERATIVELY THE PATIENT REPORTED LOW BACK PAIN PERSISTED FROM PREOPERATIVE STAGE AND WALKING WAS UNSTABLE. AFTER SURGERY, REHABILITATION TOOK A LONG TIME.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Pain Relief

  MAUDE report 6617189 ↗
• InjuryJun 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL STABILIZATION SURGERY DUE TO LUMBAR CANAL STENOSIS, IN WHICH THE IMPLANTS WAS USED. POST-OPERATIVELY THE PATIENT REPORTED LOW BACK PAIN PERSISTED FROM PREOPERATIVE STAGE AND WALKING WAS UNSTABLE. AFTER SURGERY, REHABILITATION TOOK A LONG TIME.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Pain Relief

  MAUDE report 6617188 ↗
• InjuryJun 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRE-OP DIAGNOSIS: LUMBAR CANAL STENOSIS LEVELS IMPLANTED: L4-L5 IT WAS REPORTED THAT ON UNKNOWN DATE, POST OP, IN THE SURVEY IT WAS FOUND THAT THE ZCQ SCORE OF THE PATIENT HAD VARIATIONS AND THE PATIENT DID NOT GET EFFECTIVE PAIN RELIEF.

  Patient problems: Inadequate Pain Relief

  MAUDE report 6613748 ↗
• InjuryApr 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A SURGERY, DUE TO LUMBAR SPINAL CANAL STENOSIS IN WHICH IMPLANTATION TOOK PLACE AT L3-4 LEVEL. IT WAS REPORTED THAT ON UNKNOWN DATE, POST OP, ZCQ (ZURICH CLAUDICATION SCORE)SCORE AGGRAVATION WAS OBSERVED.

  Patient problems: Stenosis

  MAUDE report 6510198 ↗

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