ELEVATE™ Spinal System NAV2133 (UDI 00643169771024)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169771024), received between Nov 13, 2019 and Jun 8, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2021Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A CONSUMER 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. 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. IT WAS REPORTED THAT THERE WAS NOT MUCH DELAY IN SURGERY DUE TO PRODUCT MALFUNCTION. NO FURTHER COMPLICATIONS WERE REPORTED. IT WAS REPORTED THAT THERE WAS SURGICAL DELAY OF 10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11953871 ↗
• MalfunctionApr 19, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH LUMBAR STENOSIS FOR TLIF SPINAL THERAPY AT L4-S1. IT WAS REPORTED THAT UPON INTRODUCTION OF THE CAGE INTO THE WOUND THE SURGEON MALLETED THE INSERTER TO ADVANCE THE CAGE AND THE CAGE WAS HITTING THE LIP OF ONE OF THE ENDPLATES AND NOT ADVANCING FORWARD INITIALLY. SURGEON CONTINUED TO MALLET TRYING TO ADVANCE CAGE INTO DISC SPACE AND CAGE ENDED UP FALLING OFF THE INSERTER. TRIED RELOADING CAGE AND COULD NOT DUE TO DAMAGED INSERTER AND INNER LOCKING TUBE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683728 ↗
• 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 11291229 ↗
• MalfunctionDec 8, 2019Break; Break

  THE PRODUCT WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9435062 ↗
• MalfunctionNov 13, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L3-5 DUE TO SPINAL STENOSIS. POST-OP, IT WAS NOTICED THAT THE VERY DISTAL-MOST TIP, APPROXIMATELY 3-4 THREADS WORTH, OF THE INNER INSERTER TUBE HAD BEEN SHEARED OFF. SURGEON WAS UNABLE TO AFFIX THE IMPLANT FOR 10-14 CASE ONTO THE INSERTER. SURGEON BELIEVED THAT THE METAL FRAGMENT WAS FLOATING LOSE INSIDE THE PATIENT, SO AN O-ARM IMAGING SCAN WAS PERFORMED IMMEDIATELY POST OP PER NORMAL PROTOCOL TO VERIFY PLACEMENT OF ALL INSTRUMENTATION. NOTHING ABNORMAL WAS OBSERVED FLOATING LOSE IN THE PATIENT. THE INSTRUMENT WAS HAND WASHED POST-OPERATIVELY AND PLACED BACK INTO ITS LOCATION IN THE SET THEN THE ENTIRE SET MACHINE WASHED, THEN WRAPPED AND STERILIZED. THERE WERE NO PATIENT COMPLICATIONS AS THE RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9314487 ↗