AVS NAVIGATOR 48393001Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327096194), received between Mar 8, 2016 and Mar 28, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionMar 28, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE CAGE PLACEMENT, THE TIP OF AN AVS NAVIGATOR INSERTER BECAME DEFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR SURGICAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13933027 ↗
• MalfunctionMar 15, 2022Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT AN AVS NAVIGATOR STRAIGHT INSERTER WAS 'BLOCKED' AND THE UNLOCKING SCREW WOULD NOT RELEASE THE CAGE INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER INSERTER AND A 10 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13764919 ↗
• MalfunctionFeb 25, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE IMPLANT PLACEMENT THE NAVIGATOR STRAIGHT INSERTER BECAME DEFORMED AT THE TIP. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR REPORTED SURGICAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13604487 ↗
• MalfunctionApr 28, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING PLACEMENT OF A CAGE WITH AN AVS NAVIGATOR STRAIGHT INSERTER, THE INSERTER TIP 'BROKE' OFF FOLLOWING TWO HAMMER BLOWS. THE CAGE AND INSERTER TIP WERE REMOVED AND CHANGED WITHOUT DIFFICULTY OR ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 10 MINUTE DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740963 ↗
• MalfunctionJul 8, 2020Material Separation; Material Deformation; Material Separation; Material Deformation

  IT WAS REPORTED THAT THE SECURING MECHANISM OF AN AVS NAVIGATOR STRAIGHT INSERTER DISENGAGED DURING INTRA-OPERATIVE IMPLANT PLACEMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATIVE INSTRUMENT. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10246787 ↗
• MalfunctionMar 22, 2017Detachment Of Device Component; Loose or Intermittent Connection; Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT; DURING SURGERY, THE INSERTER TIP BECAME LOOSE AND WAS CAME OFF THE CAGE. THE SURGERY WAS COMPLETED WITH OTHER CAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6424916 ↗
• MalfunctionMar 8, 2016Mechanical Problem; Mechanical Problem; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING THE SURGERY, THE SURGEON INSERTED THE CAGE USING THE INSERTER TO L4-L5. THE SURGEON DIDN'T NOTICE CAGE LOOSENING FROM THE INSERTER AT THE SAME TIME. WHEN THE SURGEON PUSHED THE CAGE, THE CAGE PROTRUDED ANTERIOR FROM THE VERTEBRAL BODY. THE SURGEON DID NOT REMOVE THE CAGE, AND IS MONITORING FOR THE PATIENT NOW.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 5486222 ↗