ELEVATE™ Spinal System NAV2132 (UDI 00643169771000)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00643169771000), received between Jun 18, 2020 and Jan 27, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A INSERTER USED FOR TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) THERAPY. IT WAS REPORTED THAT THE INSERTER WAS BROKEN. 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 24186214 ↗
• MalfunctionDec 31, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A INSERTER HAVING SPINAL THERAPY. IT WAS REP ORTED THAT THE INSERTER WAS BROKEN. NO FRAGMENT OF THE INSTRUMENT REMAINED IN THE PATIENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931696 ↗
• MalfunctionDec 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE INSTRUMENT EXPERIENCED BREAKAGE WHEN THE HANDLE BROKE OFF AND BECAME COMPLETELY DETACHED. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT INSTRUMENT USED MANY TIMES BEFORE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848000 ↗
• MalfunctionNov 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING A SPINAL PROCEDURE, THE HANDLE OF THE INSERTER BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE THAT THE DEVICE DAMAGED AFTER USING NUMEROUS TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23530559 ↗
• MalfunctionJul 28, 2025Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT THE INSTRUMENT TIPS WERE BENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628508 ↗
• MalfunctionJul 27, 2021Material Fragmentation; Material Fragmentation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING PATIENT IMPLANTED WITH A SPINAL PRODUCT USING AN INSERTER FOR A L5-S1 TLIF EXTENSION AND REVISION OF HARDWARE AT L3-L5. IT WAS REPORTED THAT THE SIDE METAL PIECES OF THE ELEVATE INSERTER THAT HUG THE ELEVATE CAGE BROKE OFF. ACCORDING TO THE PHYSICIAN, BOTH PIECES WERE EXTRACTED. THE INSTRUMENT 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 PRODUCT WAS USED IN OPERATION FIELD AND CAME IN CONTACT WITH THE PATIENT. THE PRE-OP DIAGNOSIS WAS LUMBAR INSTABILITY NEUROGENIC CLAUDICATION DUE TO LUMBAR SPINAL STENOSIS AND LEVELS IMPLANTED WERE L5-S1. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. THE PRODUCT WAS REPLACED BY A MEDTRONIC PRODUCT. THE PATIENT'S MEDICAL HISTORY INCLUDED DIABETES, BLOOD PRESSURE, ARTHRITIS. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230511 ↗
• 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 11605629 ↗
• MalfunctionFeb 22, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING A PATIENT WHO UNDERGONE SPINAL THERAPY WITH AN INDICATION OF STENOSIS. IT WAS REPORTED THAT DURING TLIF PROCEDURE THE TIP OF THE INSERTER BROKE OFF WHILE IMPLANTING THE ELEVATE CAGE, AND UPON INSPECTION AFTER THE CASE, THE INNER LOCKING TUBE WAS BENT AT THE TIP AND THERE WAS NO DEVICE BREAKAGE WITH INNER LOCKING TUBE. NO FRAGMENT OF THE DEVICE REMAINING IN THE PATIENT. THERE WAS SURGICAL DELAY OF 10 MINUTES. LEVELS IMPLANTED L4-5. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO ADDITIONAL SURGERY OR TREATMENT PERFORMED AS A RESULT OF THIS EVENT. PRODUCT UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11357180 ↗
• MalfunctionFeb 8, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT UNKNOWN INDICATION SUGGESTED FOR TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). EVENT OCCURRED INTRA-OP. LEVELS IMPLANTED L5-S1. IT WAS REPORTED THAT INSERTER BROKE DURING IMPACTION AND ALSO THE INNER LOCKING TUBE WAS REPORTED TO BE BROKEN. NO DEVICE FRAGMENT WAS LEFT IN PATIENT. NO PATIENT INVOLVEMENT WAS REPORTED. DEVICE ARE BEING RETURNED. PRODUCT DID COME IN CONTACT WITH PATIENT. INSERTER WAS BROKEN DURING INSERTION. THE LOCKING TUB WAS NOTICED TO BE BROKEN WHEN TRYING TO ATTACH THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11291238 ↗
• MalfunctionDec 23, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF DEGENERATIVE DISC DISEASE IN NEED OF TLIF PROCEDURE USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENT HANDLE BROKE AFTER IMPLANTING THE INTERBODY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11061898 ↗
• MalfunctionOct 30, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR SPONDYLOLITHESIS THERAPY. IT WAS REPORTED THAT THE INSERTER WAS BROKEN. THERE WAS NO FRAGMENT LEFT OR CONTACT WITH THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE INSERTER SHAFT BROKE FROM THE INSERTER HANDLE WHEN THE PHYSICIAN UNSCREWING THE INNER INSERTER TUBE TO RELEASE THE INSERTER FROM THE INTERBODY.

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

  MAUDE report 10760515 ↗
• MalfunctionJul 10, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH MULTI LEVEL DDD FOR TLIF. IT WAS REPORTED THAT THE ELEVATE INSERTER BROKE UPON INSERTING THE IMPLANT INTO A COLLAPSED DISC SPACE. THERE WAS NO FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10256841 ↗
• MalfunctionJul 10, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH MULTI LEVEL DDD FOR TLIF. IT WAS REPORTED THAT THE ELEVATE INSERTERS BROKE UPON INSERTING THE IMPLANT INTO A COLLAPSED DISC SPACE. THERE WAS NO FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10256835 ↗
• MalfunctionJul 10, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH MULTI LEVEL DDD FOR TLIF. IT WAS REPORTED THAT THE ELEVATE INSERTER BROKE UPON INSERTING THE IMPLANT INTO A COLLAPSED DISC SPACE. THERE WAS NO FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10256827 ↗
• MalfunctionJul 1, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING THE ELEVATE INSERTER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE INSERTER WAS BROKEN ON IMPLANTATION OF CAGE. 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 Known Impact Or Consequence To Patient

  MAUDE report 10216561 ↗
• MalfunctionJun 18, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LUMBAR INSTABILITY; AND UNDERWENT TRANSFORAMINAL INTERBODY LUMBAR FUSION (TLIF) AT L3-L5. INTRA-OP, ONE OF THE TABS, THAT HOLDS THE IMPLANT, BROKE. THE DOCTOR CHECKED FOR THE MISSING METAL PIECE THAT BROKE OFF THE INSERTER AND ALSO TOOK CLOSURE X-RAYS BUT HE COULD NOT SEE ANY FOREIGN BODY INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10171781 ↗