ELEVATE™ Spinal System 7770923Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169430686), received between Apr 25, 2017 and Dec 3, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (8 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, 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

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMar 5, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT IDENTIFIED DURING USE. IT WAS REPORTED THAT WHILE TESTING THE IMPLANT BEFORE BEING IMPLANTED NOT WORKING PROPERLY. NO PATIENT INVOLVED IN THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE REP THAT THIS IS A OUT OF BOX FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21523872 ↗
• MalfunctionJun 21, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAGE IN AN L4-S1 POSTERIOR INSTRUMENTATION & FUSION WITH TLIF AT L4-5 &L5-S1 FOR AN L4-S1 DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT THE CAGE WAS IMPLANTED AND EXPANDED AND NEEDED TO BE REPOSITIONED. THE CAGE COLLAPSED AND WHEN AN ATTEMPT WAS MADE TO RE-EXPAND THE CAGE, THE SCREW WOULD ONLY SPIN. THE CAGE WAS EXPLANTED AND THE SCREW WAS COMPLETELY DISASSOCIATED AND WOULD NOT EXPAND THE CAGE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE DATE OF IMPLANT AND EXPLANT WAS (B)(6) 2022. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14751428 ↗
• MalfunctionNov 10, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR LAMINECTOMY AND POSTERIOR INTERBODY, WITH MINIMALLY INVASIVE SCREWS DUE TO COLLAPSED L5/S1 DISC, DISC HERNIATION AT L4/5 <(>&<)> L5/S1. IT WAS REPORTED THAT WHEN ATTEMPTING TO IMPLANT THE ELEVATE CAGE, WHILST HAMMERING THE IMPLANT INTO THE DISC SPACE, THE SURGEON NOTED THAT THE CAGE WAS 'OPENING'. SURGEON REMOVED IT AND WHEN ENSURE THAT THE CAGE WAS CLOSE USED THE RELEVANT DRIVER. SURGEON ATTEMPTED IT AGAIN, BUT THE SAME OCCURRED AGAIN. THE PEEK PART OF THE CAGE WAS 'CATCHING' AND NOT GOING INTO THE DISC SPACE. IT WAS REPORTED THAT THE SMALL PART OF PEEK AT THE REAR OF THE CAGE HAS BROKEN OFF, HENCE WHY THE SURGEON WAS REPORTING THAT THE CAGE WAS OPENING. WE SELECTED ONE SIZE HEIGHT SMALLER CAGE, AND PREPARED IT IN THE SAME WAY AND IT INSERTED WITH NO ISSUES. THERE WERE NO PATIENT SYMPTOMS/ COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12785977 ↗
• MalfunctionJun 9, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OPEN PLIF DUE TO L4/5 DISC DISEASE. IT WAS REPORTED THAT PEEK PART OF IMPLANT SHEERED OFF IN ONE PIECE. THERE WAS NO FORCE USED AND INSERTER WAS TAPPED ONLY ONCE WITH GENTLE IMPACTION. THERE WERE NO PATIENT SYMPTOMS/ COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963868 ↗
• MalfunctionJul 9, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN UNKNOWN INDICATION FOR SPINAL THERAPY. IT WAS REPORTED THAT THE IMPLANT BROKEN INTO TWO PIECES UPON INSERTION. THERE WAS NO FRAGMENT LEFT OR CONTACT WITH THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10249245 ↗
• MalfunctionOct 11, 2019Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR INTERBODY FUSION DUE TO LUMBAR STENOSIS. INTRA-OPERATIVELY, THE CAGE WAS LOADED INTO THE INSERTER AT THE TIME OF THE EVENT, AND FILLED WITH AUTO-GRAFT FROM THE PATIENT. WHEN THE SURGEON WAS TAPPING THE IMPLANT INTO PLACE, THE CAGE POPPED OPEN AND WOULD NOT CLOSE. ALL OF THE PIECES OF THE IMPLANT WERE REMOVED BEFORE THE SURGEON PROCEEDED TO IMPLANT A DIFFERENT 8X23 MM CAGE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF ALLEGED EVENT OR NOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9179149 ↗
• MalfunctionMay 13, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-S1. INTRA-OP, THE IMPLANT BROKE DURING INSERTION. NO FRAGMENT OF THE BROKEN IMPLANT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8605298 ↗
• InjuryJan 7, 2019Break; Break

  IT WAS REPORTED THAT INTRA-OP, CAGE APPEARED TO NOT BE FULLY COLLAPSED WHEN ENTERING THE DISC SPACE AND IT WAS BELIEVED BECAUSE IT WAS NOT FULLY COLLAPSED, THE SUPERIOR PORTION OF THE IMPLANT CAPTURED A PORTION OF THE INFERIOR ASPECT OF THE L4 VERTEBRAL BODY WHERE IT WAS MALLETED INTO PLACE AND DISRUPTED THE INFERIOR ENDPLATE OF L4. THE PEEK PORTION OF THE CAGE THEN FRACTURED AND SHEARED AWAY FROM THE TITANIUM PORTION OF THE CAGE. DURAL TEAR OCCURRED TO THE PATIENT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. PATIENT HAD A FRACTURED END PLATE DUE TO THIS EVENT.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8224520 ↗
• MalfunctionAug 10, 2017Break; Break

  IT WAS REPORTED THAT INTRA-OP, THE GRAFT SEPARATED AND BROKE APART DURING SPONDYLOLISTHESIS REDUCTION. IT WAS REMOVED SUCCESSFULLY WITHOUT COMPLICATIONS. A NEW GRAFT WAS THEN IMPLANTED WITHOUT ISSUE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6783827 ↗
• MalfunctionApr 25, 2017Break; Break

  PRE-OP DIAGNOSIS: LUMBAR DISC DISEASE PROCEDURE: LUMBAR DISCECTOMY LEVELS INVOLVED: L4-L5 IT WAS REPORTED THAT THE CAGE BROKE DURING SURGERY. NO FRAGMENTS REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6517881 ↗