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VERTE-STACK® Spinal System 2961222Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SPACER 2961222 CAPS VS PK VBS END 22X12 · Class 2 · Implant

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 00885074018676), received between Feb 3, 2017 and Feb 3, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Migration or Expulsion of Device1

Patient problems

  • Numbness1
  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 3, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

    ON (B)(6) 2009 : PRE AND POST OP DIAGNOSIS: SPINAL STENOSIS L2-L3 WITH HERNIATED DISK, DEGENERATIVE DISK DISEASE, DISCO GENIC PAIN AND INSTABILITY PROCEDURE: POSTERIOR LUMBAR INTERBODY FUSION AT L2-L3; IMPLANTATION OF PEEK SPACER L2-L3; POSTERIOR NONSEGMENTED INSTRUMENT ATION L2-L3; POSTEROLATERAL FUSION L2-L3; LUMBAR LAMINECTOMY WITH FORAMINOTOMIES AND DISCECTOMY L2-L3. IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINE FUSION SURGERY ON THE LUMBAR REGION OF HER SPINE FROM VERTEBRAE L2 TO L3 USING RHBMP-2 FROM A POSTERIOR AND POSTEROLATERAL APPROACH. THE RHBMP-2 COLLAGEN SPONGE WAS PLACED OUTSIDE A CAGE (I.E., IN THE LATERAL GUTTERS). PATIENT'S POST-OPERATIVE PERIOD HAS BEEN MARKED BY PROGRESSIVELY WORSENING LOW BACK PAIN, WITH RADIATING PAIN AND NUMBNESS IN BOTH LEGS. RADIOGRAPHIC IMAGING DEMONSTRATED SUBSIDENCE OF THE INTERBODY CAGE AND BONY OVERGROWTH WHERE RHBMP-2 WAS IMPLANTED IN PATIENT'S LUMBAR SPINE. PATIENT CONTINUED TO EXPERIENCE CHRONIC LOWER BACK PAIN, WITH PAIN RADIATING TO BOTH LEGS, NUMBNESS AND TINGLING IN BOTH LEGS AND FEET, AND MUSCLE CRAMPS AND SPASMS. PATIENT EXPERIENCED DIFFICULTY IN SITTING, STANDING, AND WALKING FOR ANY EXTENDED DURATION, AND REQUIRED USE OF A

    Patient problems: Numbness; Pain

    MAUDE report 6299458 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.