AVIATOR 48811348Recalls & reported problems
Stryker Corporation · THREE-LEVEL ANTERIOR PLATE · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613252152293), received between Apr 24, 2018 and Jun 30, 2020 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (2 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
Device problems
- Fracture2
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Material Deformation1
- Migration1
Patient problems
- Injury3
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 2020Fracture; Fracture
IT WAS REPORTED THAT THE RETAINING SPRING OF AN AVIATOR ASSY THREE LEVEL PLATE BROKE AND TWO AVIATOR VARIABLE SELF DRILLING SCREWS BACKED OUT POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED AND THE TWO SCREWS HAVE BEEN REMOVED. THE PLATE REMAINS IMPLANTED. THIS REPORT WILL CAPTURE THE PLATE.
Patient problems: Injury
MAUDE report 10215161 ↗InjuryJun 23, 2020Fracture; Fracture
IT WAS REPORTED THAT AN AVIATOR ASSY 3-LEVEL PLATE SECURING MECHANISM FRACTURED AND 3 AVIATOR SCREWS MIGRATED POST-OPERATIVELY THREE WEEKS AFTER IMPLANTATION. THE PATIENT HAS UNDERGONE REVISION SURGERY AND THE SCREWS HAVE BEEN EXPLANTED. THE PLATE REMAINS IMPLANTED. THIS REPORT CAPTURES THE PLATE.
Patient problems: Injury
MAUDE report 10186553 ↗MalfunctionDec 17, 2019Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN AVIATOR 3 LEVEL CERVICAL PLATE LOCKING MECHANISM DEFORMED POST- OPERATIVELY. THERE IS NO MENTIONED PLAN OF A REVISION SURGERY AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9482078 ↗InjuryApr 24, 2018Migration; Device Dislodged or Dislocated; Migration
NOTIFIED BY SURGEON THAT SCREW APPEARS TO BE BACKING OUT OF CERVICAL PLATE. SURGEON WILL COMMIT US OBSERVATION OF HARDWARE.
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 7456250 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.