ELEVATE™ Spinal System 7770823Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169430440), received between Jan 10, 2017 and Dec 2, 2021 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAGE USING AN INSERTER IN A TLIF AT L4/5. IT WAS REPORTED THAT WHEN THE HCP PULLED THE INSERTER OFF THE CAGE, HE HAD NOTICED THAT IT BROKE INTO TWO PIECES. THE HCP USED THE REMOVAL TOOL & RETRIEVED THE BROKEN PIECES. A NEW CAGE WAS IMPLANTED WITH NO ISSUES. THE DATE OF IMPLANT AND EXPLANT WAS (B)(6) 2021. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THERE WAS NO OTHER INTERVENTIONS NEEDED FOR THIS CASE. THE PATIENT'S MEDICAL HISTORY INCLUDES SPODYLOLISTHESIS.  NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12914750 ↗
• InjuryNov 26, 2021Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT THE WORKING TIP OF THE EXPANSION SCREWDRIVER SNAPPED OFF INSIDE THE SCREW OF THE ELEVATE CAGE. IT WAS NOT REALIZED UNTIL THE INSTRUMENT WAS TAKEN OUT AND EXAMINED THE TIP. THERE WAS NO WAY TO EXTRACT THE SCREW TIP FROM THE CAGE, AND IT IS STILL IN THE PATIENT. THE ELEVATE CAGE MIGRATED AND PATIENT HAD LEG PAIN AND NUMBNESS. REVISION WAS PERFORMED TO PUT CAGE BACK INTO PLACE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Numbness; Pain

  MAUDE report 12876874 ↗
• MalfunctionApr 7, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPACER FOR A TLIF. IT WAS REPORTED THAT THE PEEK PORTION OF THE IMPLANT MADE CONTACT WITH THE SUPERIOR PORTION OF THE ENDPLATE, CAUSING IT TO SNAP OFF THE METAL PORTION OF THE ELEVATE CAGE. THE SPACER BROKE UPON INSERTION. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE DATE OF IMPLANT AND EXPLANT WAS (B)(6) 2021 . THE PRE-OP DIAGNOSIS AND LEVELS IMPLANTED ARE UNKNOWN. THERE WAS NO DELAY IN SURGERY TIME OR PATIENT HARM. THE PRODUCT WAS REPLACED BY A MEDTRONIC PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11625836 ↗
• MalfunctionJul 3, 2019Mechanical Problem; Malposition of Device; Mechanical Problem; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT L4-L5 POSTERIOR LUMBAR INTERBODY FUSION. INTRA-OP, AFTER PLACING THE IMPLANT IN THE DISC SPACE AT L4-L5, IT LOOKED AS IF THE SURGEON IMPLANTED THE CAGE TOO FAR INTO THE DISC SPACE. HE TRIED TO RECONNECT THE INSERTER TO THE IMPLANT BUT WAS UNABLE TO DO SO. HE THEN COLLAPSED THE CAGE. RETRIEVAL OF CAGE WAS ATTEMPTED AGAIN BUT IT COULD NOT BE DONE. THE SURGEON THEN DISTRACTED THE DISC SPACE AND TRIED TO RECONNECT THE INSERTER TO THE IMPLANT. WHEN TRYING TO RECONNECT THE CAGE TO THE INSERTER, THE CAGE WAS PUSHED ANTERIORLY, AND OUT OF THE DISC SPACE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED CURRENTLY; HOWEVER, THE PATIENT IS GOING TO BE EVALUATED BY THE SURGEON DURING FOLLOW-UP. IF ANY SYMPTOMS OCCUR FROM THE CAGE IN THE ANTERIOR SPACE, THE SURGEON WILL SCHEDULE A SURGERY BY ANTERIOR APPROACH TO RETRIEVE THE IMPLANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8756695 ↗
• MalfunctionJan 10, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L3-L4 DUE TO SPINAL STENOSIS . INTRA-OP, THE CAGE BROKE. NO FRAGMENTS OF THE IMPLANT REMAINED IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8234606 ↗
• MalfunctionJan 10, 2017Break; Break

  IT WAS REPORTED THAT PATIENT WITH DEGENERATIVE DISC DISEASE AT L3/4 AND L4/5 UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L3-L5. INTRA-OP, DURING INSERTION OF THE IMPLANT, SURGEON NOTICED THAT THE PEEK PORTION OF THE IMPLANT BROKE. IMPLANT REMOVED AND REPLACED WITH NEW IMPLANT. ALL PIECES WERE REMOVED FROM PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6235868 ↗
• MalfunctionJan 10, 2017Break; Break

  IT WAS REPORTED THAT PATIENT WITH DEGENERATIVE DISC DISEASE AT L3/4 AND L4/5 UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L3-L5. INTRA-OP, DURING INSERTION OF THE IMPLANT, SURGEON NOTICED THAT THE PEEK PORTION OF THE IMPLANT BROKE. IMPLANT REMOVED AND REPLACED WITH NEW IMPLANT. ALL PIECES WERE REMOVED FROM PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6235867 ↗