AVIATOR 48811118Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252152132), received between Mar 7, 2017 and Apr 3, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Bent” (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
- Bent1
- Break1
- Failure to Advance1
- Fracture1
- Material Deformation1
- Material Integrity Problem1
Patient problems
- No Information2
- Injury1
- 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.
MalfunctionApr 3, 2017Bent; Failure to Advance; Material Deformation; Material Deformation
IT WAS REPORTED THAT; 18MM PLATE WAS IMPLANTED & WHEN TRYING TO TIGHTEN SCREWS DOWN SURGEON WAS UNABLE TO GET PASS SPRING BAR. END WAS BENT NOT ALLOWING SCREW TO ENGAGE. PLATE WAS REMOVED AND NEW SELECTED WITH RESCUE SCREW USED.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 6455178 ↗InjuryMar 7, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT; I WAS IN OPERATING ROOM ON THE MORNING OF FRIDAY, (B)(6) 2017 AT 7:30AM FOR AN PLATE AND SCREW REMOVAL. AFTER REMOVING THE PLATE, I NOTICED AN EYELET WAS BROKEN. I INFORMED THE SURGEON OF THIS. HE LATER FOUND THE BROKEN PIECE INSIDE OF THE PATIENT AND PLACED IT WITH THE PLATE IN A SPECIMEN CUP, WHICH I HAVE IN MY POSSESSION.
Patient problems: Injury; No Information
MAUDE report 6384562 ↗
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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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