AVS NAVIGATORRecalls & reported problems across all models
Stryker Corporation · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 12 models of AVS NAVIGATOR by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Feb 10, 2016 and May 28, 2025 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Fracture” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported AVS NAVIGATOR problems
Device problems
- Fracture12
- Break10
- Material Deformation6
- Detachment Of Device Component4
- Material Integrity Problem4
- Device Dislodged or Dislocated3
- Mechanical Jam3
- Mechanical Problem2
Patient problems
- No Known Impact Or Consequence To Patient15
- No Consequences Or Impact To Patient7
- No Clinical Signs, Symptoms or Conditions6
- Device Embedded In Tissue or Plaque1
- No Code Available1
AVS NAVIGATOR models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AVS NAVIGATOR 48393001Intervertebral fusion device with bone graft, lumbar7 reports
- AVS NAVIGATOR 48394005ORTHOPEDIC MANUAL SURGICAL INSTRUMENT5 reports
- AVS NAVIGATOR 48393002Intervertebral fusion device with bone graft, lumbar2 reports
- AVS NAVIGATOR 48392080Intervertebral fusion device with bone graft, lumbar2 reports
- AVS NAVIGATOR 48392094Intervertebral fusion device with bone graft, lumbar1 report
- AVS NAVIGATOR 48392084Intervertebral fusion device with integrated fixation, lumbar1 report
- AVS NAVIGATOR 48392104Intervertebral fusion device with integrated fixation, lumbar1 report
- AVS NAVIGATOR 48392110Intervertebral fusion device with integrated fixation, lumbar1 report
- AVS NAVIGATOR 48392114Intervertebral fusion device with bone graft, lumbar1 report
- AVS NAVIGATOR 48393110Intervertebral fusion device with integrated fixation, lumbar1 report
- AVS NAVIGATOR 48393150Intervertebral fusion device with bone graft, lumbar1 report
- AVS NAVIGATOR 48394006ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent AVS NAVIGATOR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2025Fracture; Material Deformation; Mechanical Jam; Fracture; Material Deformation; Mechanical Jam
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22102449 ↗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 23, 2022Mechanical Jam; Insufficient Device Problem Information; Mechanical Jam; Insufficient Device Problem Information
IT WAS REPORTED THAT AN AVS NAVIGATOR BAYONETED UPLIF INSERTER WAS 'CURED/BAKED'. THE DEVICE WAS NOT LUBRICATED DURING THE INSPECTION AS PER SURGICAL TECHNIQUE. SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER 'IMPACTOR' AND A 30 MINUTE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13860935 ↗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 ↗MalfunctionAug 29, 2019Fracture
IT WAS REPORTED THAT THE SECURING MECHANISM OF AN AVS NAVIGATOR PEEK CAGE FRACTURED DURING INSERTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO IMPLANT FRAGMENTS REMAIN INSIDE THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8947232 ↗MalfunctionAug 8, 2019Break; Fracture; Fracture
IT WAS REPORTED THAT A NAVIGATOR UPLIF SPACER BROKE UPON INSERTION, ¿DUE TO TIGHT DISC SPACE.¿ THE SURGERY WAS SUCCESSFULLY COMPLETED USING A CAGE WHICH WAS 2 MM SHORTER AFTER A 3-MINUTE SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8875933 ↗MalfunctionJul 6, 2018Break; Fracture; Fracture
THE CAGE TAIL BROKE DURING INSERTION. NO RESPONSE WAS RECEIVED FROM THE STRYKER REPRESENTATIVE REGARDING ADDITIONAL INFORMATION. NO ADVERSE CONSEQUENCES OR SURGICAL DELAY WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7667802 ↗MalfunctionFeb 16, 2018Fracture; Device Operates Differently Than Expected; Noise, Audible; Fracture
THE SURGEON REPORTED THAT A DISTRACTOR FAILED SUDDENLY DURING DISTRACTION, DURING A TLIF MINI INVASIVE L4 L5 SURGERY. THE SURGEON REPORTED HEARING A "CLACK" AND THOUGHT A PIECE BROKE INSIDE THE MECHANISM. THE MECHANISM DID NOT SEIZE. THE SURGEON WAS ABLE TO RETRACT THE INSTRUMENT TO REMOVE IT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7278677 ↗MalfunctionDec 28, 2017Break; Detachment Of Device Component; Fracture; Fracture
IT WAS REPORTED THAT; HANDLE BROKE OFF OF INSTRUMENT AND PART OF IT IS STUCK IN THREAD.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7150884 ↗MalfunctionAug 28, 2017Break
IT WAS REPORTED THAT; THIS DEVICE WAS USED AT AN EXTREME ANGLE UNDER EXCEEDING PRESSURE. UPDATE 8/2/2017: THE TIP BROKE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6825873 ↗MalfunctionAug 28, 2017Break
IT WAS REPORTED THAT: THIS DEVICE WAS USED AT AN EXTREME ANGLE UNDER EXCEEDING PRESSURE UPDATE (B)(6) 2017: THE TIP BROKE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6825871 ↗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 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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