AVIATOR 48811112Recalls & reported problems
Stryker Corporation · ONE-LEVEL ANTERIOR PLATE · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252152101), received between May 17, 2016 and Aug 29, 2017 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Device Slipped1
- Material Deformation1
- Mechanical Problem1
Patient problems
- No Known Impact Or Consequence To Patient2
- Injury1
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2017Device Dislodged or Dislocated
IT WAS REPORTED THAT; SPRING BAR POPPED OUT OF ITS GROOVE WHILE THE SURGEON WAS ROTATING THE SECONDARY LOCK MECHANISM. THE PLATE WAS EXPLANTED AND REPLACED WITH ANOTHER PLATE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6826508 ↗MalfunctionJun 30, 2017Material Deformation
IT WAS REPORTED THAT; 12 MM PLATE SPRING BAR WAS DEFORMED WHILE SURGEON WAS IMPLANTING. BACK UP 12 MM PLATE WAS USED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6681584 ↗InjuryMay 17, 2016Mechanical Problem; Device Slipped; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT A PLATE THAT WAS IMPLANTED ON (B)(6) 2015 BECAUSE ONE OF THE SCREWS WAS BACKING OUT.
Patient problems: Injury; No Information
MAUDE report 5661429 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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