ELEVATE™ Spinal System 7771023Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169430679), received between Apr 10, 2017 and Sep 25, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2024No Apparent Adverse Event; No Apparent Adverse Event

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4-S1 MINIMALLY INVASIVE ROBOTIC TLIF FOR AN INDICATION OF L4/S1 DEGENERATION. IT WAS REPORTED THAT THE INSERTER TIP BROKE OFF DURING INSERTION OF CAGE AND THERE WAS ONLY ONE INSERTER ON THE SET, THEREFORE THE CAGE THEN HAD TO BE PULLED OUT AND NOT USED AS IT WAS NOT INSERTED COMPLETELY WHEN IT BROKE. THE SURGEON HAD TO USE ANOTHER TYPE OF CAGE THE HOSPITAL HAD ON SHELF. 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 20298181 ↗
• MalfunctionMay 15, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH STENOSIS FOR TWO LEVEL OPEN TLIF. IT WAS REPORTED THAT INTRA-OPERATIVELY, CAGE BROKE DURING INSERTION. IT WAS SPLIT BETWEEN THE PEEK AND TITANIUM PORTION. THE PRODUCT CAME IN CONTACT WITH PATIENT AND THE PRODUCT BROKE WILL TRYING TO INSERT THE CAGE INTO THE DISC SPACE. LEVELS IMPLANTED WAS L4/5. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11830057 ↗
• MalfunctionApr 10, 2017Break; Break

  PRE-OPERATIVE DIAGNOSIS: INTERVERTEBRAL DISC DISORDERS WITH RADICULOPATHY L4-S1 LEVEL IMPLANTED: L4-L5 IT WAS REPORTED THAT DURING SURGERY, THE SPACER BROKE BEFORE COMPLETE INSERTION. NO FRAGMENT OF THE IMPLANT REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6474725 ↗