AVS NAVIGATOR 48393002Recalls & reported problems
Stryker Corporation · BAYONETED INSERTER · Class 2
All models of AVS NAVIGATOR (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540665720), received between Nov 1, 2016 and Mar 23, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Falling” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Component Falling1
- Detachment Of Device Component1
- Detachment of Device or Device Component1
- Insufficient Device Problem Information1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionNov 1, 2016Detachment of Device or Device Component; Detachment Of Device Component; Component Falling; Detachment of Device or Device Component
IT WAS REPORTED THAT A CAGE WAS BEING LOADED ON THE INSERTER. WHILE ATTEMPTING TO LOCK THE GRAFT TO THE INSERTER, THE LOCK SLIDE ON THE INSERTER FELL OFF.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6071344 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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