ELEVATE™ Spinal System 8657002Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169432185), received between Aug 20, 2020 and Nov 26, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL FUSION THERAPY. IT WAS REPORTED THAT BOTH THE INNER SLEEVES COMING OUT, AND THE DISTAL THREADS OF THE ELEVATE INNER SLEEVE BREAKING OFF. IT WAS CONFIRMED THAT NO FRAGMENT OF THE INSTRUMENT REMAINED IN THE PATIENT. THERE WAS NO PATIENT INVOLVED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23654354 ↗
• MalfunctionApr 5, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING INSTRUMENTS USED FOR SPINAL SURGERY. PROCEDURE PERFORMED IN THE EVENT WAS TLIF. PRE-OP DIAGNOSIS WAS STENOSIS. IT WAS REPORTED THAT INTRA-OPERATIVELY, THREADS OF THE INSERTER INNER LOCKING TUBE WERE BROKEN. THE PRODUCT CAME IN CONTACT WITH PATIENT. THERE WAS NO DELAY IN THE OVERALL PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14015310 ↗
• MalfunctionSep 24, 2021Break; Material Deformation; Break; Material Deformation

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT FOR SPINAL THERAPY. IT WAS REPORTED THAT THE BROKEN SERRATION OF CAGE INSERTER FOR ELEVATE CAGE. INABILITY TO ENGAGE PROPERLY ON IMPLANT. THERE WAS NO PATIENT SYMPTOMS REPORTED IN THIS EVENT. ADDITIONAL INFORMATION RECEIVED STATES THAT ELEVATE INSERTER WAS STRIPPED AT TIME OF INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12524440 ↗
• MalfunctionApr 1, 2021Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING NAVIGATION AND SPINAL INSTRUMENTS BEING USED INTRA-OPERATIVELY OF A SPINAL PROCEDURE. IT WAS REPORTED THAT INSTRUMENTS BROKE DUE TO HARD PATIENT BONES. THERE WAS NO DELAY AND NO IMPACT ON THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11605763 ↗
• MalfunctionApr 1, 2021Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING NAVIGATION AND SPINAL INSTRUMENTS BEING USED INTRA-OPERATIVELY OF A SPINAL PROCEDURE. IT WAS REPORTED THAT INSTRUMENTS BROKE DUE TO HARD PATIENT BONES. THERE WAS NO DELAY AND NO IMPACT ON THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11605700 ↗
• MalfunctionNov 26, 2020Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT THAT OCCURRED DURING AN L3-4-5-1 TLIF PROCEDURE IN A PATIENT DIAGNOSED WITH SPINAL CORD STENOSIS. IT WAS REPORTED THAT THE THREADS WERE BROKEN. PRODUCT WAS RETURNED, AND IT WILL BE REPLACED WITH A MEDTRONIC PRODUCT. NO PATIENT INJURY / COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10910526 ↗
• MalfunctionOct 14, 2020Break; Material Deformation; Break; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR SPINAL STENOSIS PROCEDURE. IT WAS REPORTED THAT THE SURGEON NOTICED SHAVINGS FROM THREADED SHAFT WHEN ATTACHING IMPLANT. DURING IMPLANTATION BOTH TABS BROKE OFF ON INSERTER. 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 Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10675900 ↗
• MalfunctionAug 20, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF L3/4;L4-S1 PLIF. IT WAS REPORTED THAT INTRA-OP, INSERTER ELEVATE AND ITS INNER LOCKING TUBE BREAK. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. PRODUCTS WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10429933 ↗