NA 626678Recalls & reported problems
Stryker GmbH · One-Third Tubular Plate · Class 2 · Implant
Data updated Oct 18, 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 07613327088823), received between Jan 30, 2023 and Mar 27, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture2
Patient problems
- Discomfort1
- Failure of Implant1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 27, 2025Break; Fracture; Break; Fracture
AS REPORTED: "THE SURGEON HAD TO REOPEN ONE OF HIS PATIENTS BECAUSE THE PLATE PLACED ON (B)(6) 2024 WAS BROKEN."
Patient problems: Insufficient Information
MAUDE report 21713264 ↗InjuryJan 30, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT A VARIAX PLATE WAS IMPLANTED ON (B)(6) 2022. IN MID-NOVEMBER 2022, PATIENT NOTICED SOMETHING WAS NOT RIGHT. ON (B)(6) 2023, BROKEN PLATE WAS REMOVED.
Patient problems: Discomfort; Failure of Implant
MAUDE report 16268648 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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