ELEVATE Spinal SystemRecalls & reported problems across all models

We found 33 models of ELEVATE Spinal System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 296 adverse event reports in the FDA's MAUDE database, received between Jan 10, 2017 and Sep 28, 2026 — classified as 26 injuries, 270 malfunctions.

The most frequently reported specific device problem is “Break” (246 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ELEVATE Spinal System problems

ELEVATE Spinal System models

33 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ELEVATE™ Spinal System 7770723

  Intervertebral fusion device with bone graft, lumbar
  65 reports
• ELEVATE™ Spinal System 8880923

  Intervertebral fusion device with bone graft, lumbar
  27 reports
• ELEVATE™ Spinal System 8657003

  Intervertebral fusion device with bone graft, lumbar
  23 reports
• ELEVATE™ Spinal System 8657001

  Intervertebral fusion device with bone graft, lumbar
  19 reports
• ELEVATE™ Spinal System 8880823

  Intervertebral fusion device with bone graft, lumbar
  17 reports
• ELEVATE™ Spinal System 7770728

  Intervertebral fusion device with bone graft, lumbar
  16 reports
• ELEVATE™ Spinal System NAV2132

  Orthopedic stereotaxic instrument
  16 reports
• ELEVATE™ Spinal System 8880928

  Intervertebral fusion device with bone graft, lumbar
  12 reports
• ELEVATE™ Spinal System 7770923

  Intervertebral fusion device with bone graft, lumbar
  11 reports
• ELEVATE™ Spinal System 8880828

  Intervertebral fusion device with bone graft, lumbar
  10 reports
• ELEVATE™ Spinal System NAV2132

  Orthopedic stereotaxic instrument
  10 reports
• ELEVATE™ Spinal System 8657002

  Intervertebral fusion device with bone graft, lumbar
  8 reports
• ELEVATE™ Spinal System 7770823

  Intervertebral fusion device with bone graft, lumbar
  7 reports
• ELEVATE™ Spinal System NAV2132

  Orthopedic stereotaxic instrument
  6 reports
• ELEVATE™ Spinal System 7770828

  Intervertebral fusion device with bone graft, lumbar
  5 reports
• ELEVATE™ Spinal System NAV2133

  Orthopedic stereotaxic instrument
  5 reports
• ELEVATE™ Spinal System 7771028

  Intervertebral fusion device with bone graft, lumbar
  4 reports
• ELEVATE™ Spinal System 8881023

  Intervertebral fusion device with bone graft, lumbar
  4 reports
• ELEVATE™ Spinal System 7771023

  Intervertebral fusion device with bone graft, lumbar
  3 reports
• ELEVATE™ Spinal System 7771128

  Intervertebral fusion device with bone graft, lumbar
  3 reports
• ELEVATE™ Spinal System 8881123

  Intervertebral fusion device with bone graft, lumbar
  3 reports
• ELEVATE™ Spinal System 8881128

  Intervertebral fusion device with bone graft, lumbar
  3 reports
• ELEVATE™ Spinal System NAV2134

  Orthopedic stereotaxic instrument
  3 reports
• ELEVATE™ Spinal System 7770928

  Intervertebral fusion device with bone graft, lumbar
  2 reports
• ELEVATE™ Spinal System 7770832

  Intervertebral fusion device with bone graft, lumbar
  2 reports
• ELEVATE™ Spinal System 8881028

  Intervertebral fusion device with bone graft, lumbar
  2 reports
• ELEVATE™ Spinal System 8657005

  Intervertebral fusion device with bone graft, lumbar
  2 reports
• ELEVATE™ Spinal System 8657007

  Intervertebral fusion device with bone graft, lumbar
  2 reports
• ELEVATE™ Spinal System NAV2133

  Orthopedic stereotaxic instrument
  2 reports
• ELEVATE™ Spinal System 7770732

  Intervertebral fusion device with bone graft, lumbar
  1 report
• ELEVATE™ Spinal System 8880932

  Intervertebral fusion device with bone graft, lumbar
  1 report
• ELEVATE™ Spinal System 8657008

  Intervertebral fusion device with bone graft, lumbar
  1 report
• ELEVATE™ Spinal System NAV2133

  Orthopedic stereotaxic instrument
  1 report

Recent ELEVATE Spinal System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  Information was received from multiple sources (Healthcare Provider, Distributor) regarding a patient having Minimally Invasive Tran sforaminal Lumbar Interbody Fusion for L3-L4 herniated intervertebral disc (HIVD). It was reported that after the cage was implanted and expanded, an X-ray was taken to confirm its position. The imaging revealed that the PEEK component had separated and broken. The surgeon did the same procedure with the new one, the cage separated and broken too. A new cage of the bigger size was selected and implanted. This replacement expanded successfully without further complications, and the surgery was completed as planned. There were no patient symptoms reported. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912231 ↗
• MalfunctionSep 28, 2026Break

  Information was received from multiple sources (Healthcare Provider, Distributor) regarding a patient having Minimally Invasive Tran sforaminal Lumbar Interbody Fusion for L3-L4 herniated intervertebral disc (HIVD). It was reported that after the cage was implanted and expanded, an X-ray was taken to confirm its position. The imaging revealed that the PEEK component had separated and broken. The surgeon did the same procedure with the new one, the cage separated and broken too. A new cage of the bigger size was selected and implanted. This replacement expanded successfully without further complications, and the surgery was completed as planned. There were no patient symptoms reported. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912163 ↗
• MalfunctionJun 1, 2026Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A DEVICE US ED IN A SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE INSERTER WAS BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25353615 ↗
• MalfunctionMay 26, 2026Mechanical Problem; Material Deformation

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DEVICE USED FOR HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING EQUIPMENT INSPECTION, THE USER TESTED THE THREADED INNER TUBE OF THE ELEVATE SYSTEM BY THREADING IT INTO THE OUTER INSERTER SLEEVE AND NOTICED THAT IT WAS BECOMING INCREASINGLY DIFFICULT TO SCREW IN. THE USER TRIED THREE DIFFERENT THREADED INNER TUBES, BUT ALL SHOWED THE SAME DIFFICULTY. BASED ON THIS, THE USER CONCLUDED THAT THE OUTER INSERTER WAS BREAKING DOWN ON ITS INTERNAL THREADS. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273794 ↗
• MalfunctionMar 30, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ENDOLIF (ENDO F USION). IT WAS REPORTED THAT THE CAGE FRACTURED INTO FRAGMENTS WHILE BEING INSERTED INTO THE PATIENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24725950 ↗
• MalfunctionMar 11, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, INSERTER WOULD NOT INSERT INTO IMPLANT. IT WAS LATER FOUND THAT THE INSERTER HAD SEVERAL THREADS THAT HAD BEEN BROKEN OFF. PROCEDURE/TECHNIQUE PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5/S. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED. THERE WAS NO ALLEGATION/MALFUNCTION ASSOCIATED WITH REPORTED CAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575115 ↗
• MalfunctionMar 11, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT WHILE IMPLANTING AN ELEVATE INTERBODY, ONE OF THE PRONGS AT THE DISTAL END OF THE INSERTER WHICH WAS HOLDING THE IMPLANT IN THE PROPER ORIENTATION BROKE OFF OF THE INSERTER. ANOTHER INSERTER WAS USED TO COMPLETE THE INTERBODY INSERTION SUCCESSFULLY AND THE BROKEN PRONG WAS RECOVERED. NO DELAY TO PROCEDURE OR COMPLICATIONS TO PATIENT.. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569833 ↗
• MalfunctionFeb 10, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER WAS FOUND TO HAVE A STRIPPED TIP, WAS NOT IN PROPER WORKING CONDITION, AND EXPERIENCED INSTRUMENT BREAKAGE. THE ISSUE WAS IDENTIFIED BY SURGICAL TECHNICAL STAFF PRIOR TO THE BEGINNING OF THE CASE, AND THE TIP OF THE INSERTER COULD NOT ENGAGE THE IMPLANT. THERE WAS NO PATIENT WAS INVOLVED. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE INSTRUMENT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24301565 ↗
• MalfunctionJan 27, 2026Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A INSERTER USED FOR TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) THERAPY. IT WAS REPORTED THAT THE INSERTER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24186214 ↗
• MalfunctionJan 6, 2026Break; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A INSERTER USED FOR SPINAL THERAPY. IT WAS R EPORTED THAT THE INSERTER TIP WAS BENT. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE HANDLE BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973757 ↗
• MalfunctionJan 5, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING INSERTERS. IT WAS REPORTED THAT INSERTERS WERE BROKEN AS HANDLES BROKE ON BOTH. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960365 ↗
• MalfunctionJan 5, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING INSERTERS. IT WAS REPORTED THAT INSERTERS WERE BROKEN AS HANDLES BROKE ON BOTH. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960340 ↗
• MalfunctionDec 31, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A INSERTER HAVING SPINAL THERAPY. IT WAS REP ORTED THAT THE INSERTER WAS BROKEN. NO FRAGMENT OF THE INSTRUMENT REMAINED IN THE PATIENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931696 ↗
• MalfunctionDec 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE INSTRUMENT EXPERIENCED BREAKAGE WHEN THE HANDLE BROKE OFF AND BECAME COMPLETELY DETACHED. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT INSTRUMENT USED MANY TIMES BEFORE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848000 ↗
• MalfunctionDec 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L5/S1 BILATERAL TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) FOR L5 RADICULOPATHY. IT WAS REPORTED THAT DURING INSERTION THE SUPERIOR PEEK PORTION OF THE ELEVATE CAGE BROKE APART. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23702163 ↗

Other Medtronic Sofamor Danek, Inc. products

• CD HORIZON Spinal System342 models · 2,323 reports
• GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM)25 models · 12 reports · 14 recalls
• METRx System5 models · 672 reports
• INFUSE Bone Graft6 models · 576 reports · 1 recall
• CD HORIZON SOLERA VOYAGER Spinal System60 models · 411 reports
• POWEREASE Instruments8 models · 331 reports · 1 recall
• Catalyft PL Expandable Interbody System16 models · 279 reports · 1 recall
• INFINITY Occipitocervical Upper Thoracic System35 models · 63 reports · 5 recalls