ELEVATE™ Spinal System 8880828Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169430815), received between Apr 28, 2017 and Mar 11, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2025Material Deformation; Mechanics Altered; Material Deformation; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A USER FACILITY(UF) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPINAL DEVICE USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE LOCKING SCREW AT THE DISTAL END OF THE IMPLANT WAS STRIPPED, THE IMPLANT COULD NOT EXPAND AND TIGHTEN. THERE WAS NO PATIENT INVOLVEMENT IN THE EVENT AND NO FURTHER COMPLICATIONS/SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE DISTAL END OF THE DRIVER WAS WORN DOWN SO IT WOULDN'T PROPERLY ENGAGE WITH ANY UNIVERSAL HANDLE THAT WE WOULD TRY TO PAIR IT WITH AND THE LOCKING MECHANISM ON BOTH DRIVERS WOULD NOT STAY LOCKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21580440 ↗
• MalfunctionJul 23, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE SUPERIOR PORTION OF THE DEVICE BROKE WHEN MAKING CONTACT WITH THE PATIENT¿S END PLATES. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805315 ↗
• MalfunctionAug 22, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT WAS LOST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17593352 ↗
• MalfunctionFeb 16, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT FOR UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE GRAFT WAS BROKEN INTO TWO PIECES DURING INSERTION. NO BROKEN PIECES WERE LEFT IN THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13541782 ↗
• MalfunctionNov 15, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH MEDICAL HISTORY OF AFIB, CARDIAC STENT, PROSTATE CANCER <(>&<)> HYPERTENSION. IT WAS REPORTED THAT THE CAGE BROKEN IN HALF WHILE IMPLANTING. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ALL THE FRAGMENTS OF BROKEN CAGE WERE RETRIEVED FROM THE PATIENT BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12808861 ↗
• MalfunctionJan 17, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT INVOLVED IN BI-LATERAL ONE LEVEL, TLIF PROCEDURE. IT WAS REPORTED THAT AT INTRA-OP, WHEN THE CAGE WAS BEING IMPLANTED, THE PEEK TOP PORTION OF THE CAGE WAS SHEARED OFF AND SPLIT THE IMPLANT IN HALF RENDERING IT USELESS. NO HARM TO THE PATIENT, BROKEN CAGE WAS TAKEN OUT FROM THE INSERTER AND REPLACED BY ANOTHER MEDTRONIC PRODUCT. WHEN EXAMINED THE IMPLANT AND THE DISC SPACE, THERE WERE NO BROKEN FRAGMENTS LEFT IN THE PATIENT¿S BODY. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11182913 ↗
• MalfunctionDec 22, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PREOP DIAGNOSIS- DEGENERATE FUSION, PRIOR LAMI, REVISION INVOLVED IN TLIF PROCEDURE. IT WAS REPORTED THAT DURING PROCEDURE, PRODUCT BROKE WHILE TRYING TO INSERT THE IMPLANT IN SMALLER DISC SPACE IN THE PATIENT. THERE WERE NO FRAGMENTS LEFT IN THE PATIENT¿S BODY. PRODUCT WAS REPLACED WITH MEDTRONIC PRODUCT. ALLEGED PRODUCT WAS NOT IMPLANTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. PATIENT IS ALIVE - NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11053642 ↗
• MalfunctionFeb 12, 2018Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE GRAFT BROKE INTO TWO PIECES AS IT WAS BEING IMPLANTED INTO THE DISC SPACE. NO PATIENT COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7262806 ↗
• MalfunctionAug 9, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, INTRA-OP, AN 8 MM AN EXPANDABLE LUMBAR CAGE BROKE WHILE INSERTING INTO PATIENT BEFORE DISTRACTION. THE PRODUCT WAS REPLACED WITH AN 10 MM CAGE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6776260 ↗
• MalfunctionApr 28, 2017Break; Break

  IT WAS REPORTED THAT PATIENT WITH DISC HERNIATION/SPINAL STENOSIS UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L4/5. INTRA-OP,WHEN THE SURGEON INSERTED THE DEVICE, HALF OF IT SHEARED OFF WITHIN THE DISC SPACE. THE SPACER BROKE INTO 3-4 PIECES. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONALLY IT WAS REPORTED THAT STIFF/IMMOBILE DISC OF PATIENT MIGHT HAVE PUT ADDITIONAL STRAIN ON DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6528953 ↗