ELEVATE™ Spinal System NAV2132 (UDI 00763000141400)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000141400), received between Aug 4, 2021 and Nov 27, 2025 — classified as 10 malfunctions.

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

• MalfunctionNov 27, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE HANDLE WAS COMPLETELY SNAPPED OFF. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23665355 ↗
• MalfunctionNov 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR TRANSFORAMINAL LUMBAR INTE RBODY FUSION SPINAL THERAPY. IT WAS REPORTED THAT THE NAV ELEVATE INSERTER WAS FOUND BROKEN INTO THREE PIECES IN THE STERILE PROCESSING DEPARTMENT. NO PATIENT WAS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT HE HAS NO IDEA OF WHEN THE INSERTER HAS BEEN BROKEN DURING INITIAL OR IN THE RE-USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23460611 ↗
• MalfunctionOct 22, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A INSERTER USED FOR SPINAL THERAPY. IT WAS R EPORTED THAT THE FRAME IN THE INSERTER BROKE. PRODUCT WAS USED NUMEROUS TIMES PRIOR TO THIS CASE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356084 ↗
• MalfunctionDec 23, 2022Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT PRE OP DIAGNOSIS FOR THE EVENT WAS L3-S1,INSERTER CAME INTO CONTACT WITH PATIENT DURING INSERTION AND NO BROKEN PIECES WERE LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16044675 ↗
• MalfunctionDec 23, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN TLIF THERAPY. LEVELS IMPLANTED: L3-S1 IT WAS REPORTED THAT ONE OF THE PRONGS ON THE INSERTER BROKE OFF WHILE BEING MALLETED IN. THE DEVICE CAME IN CONTACT WITH THE PATIENT, BUT NONE OF THE BROKEN PIECES OF THE INSERTER REMAINED IN THE PATIENT. THERE WAS AN INCREASE IN PROCEDURE TIME OF ABOUT 20 MINUTES. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16041825 ↗
• MalfunctionDec 5, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF FOR LUMBAR STENOSIS. IT WAS REPORTED THAT THE INSERTER BROKE. NO FRAGMENT WAS LEFT INSIDE THE PATIENT. 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 15912954 ↗
• MalfunctionApr 27, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MIS L4-S1 FUSION DUE TO UNKNOWN INDICATION. IT WAS REPORTED THAT INSERTER BROKE NEAR THE HANDLE AS WE WERE IMPACTING THE CAGE INTO PLACE. NOBODY WAS HARMED DURING THE INCIDENT AND THE INSERTER DID NOT ACTUALLY FALL APART UNTIL AFTER THE CASE. CAGES WERE IMPLANTED SUCCESSFULLY AND NO COMPLICATIONS WERE CAUSED. 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 14218474 ↗
• MalfunctionDec 1, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR STENOSIS. PROCEDURE PERFORMED WAS MLIF THERAPY. IT WAS REPORTED THAT WHILE USING MALLET TO INSERT IMPLANT, THE JOINT ON THE INSERTER BY THE HANDLE WAS BROKEN. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. INSERTER CAME INTO CONTACT WITH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12906223 ↗
• MalfunctionOct 26, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING NAVIGATED TLIF FOR SPONDYLOLITHESIS L5-S1. IT WAS REPORTED THAT ONE OF THE INSERTER WAS BROKEN. BROKEN INSERTER WAS USED ON PATIENT. THERE WAS NO SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12696173 ↗
• MalfunctionAug 4, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING AN INSERTER FOR A SPINAL FUSION. IT WAS REPORTED THAT THE INSERTER BROKE AND THERE WAS NO FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT'S BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE INSERTER WAS USED DURING THE SURGERY AND THEREFORE CAME IN CONTACT WITH THE PATIENT AND WAS USED IN THE OPERATION FIELD. THE PRE-OP DIAGNOSIS WAS L4-S1 SPONDYLOLISTHESIS/STENOSIS AND LEVELS IMPLANTED WERE L4/5. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12272739 ↗