NA 626676Recalls & reported problems
Stryker GmbH · One-Third Tubular Plate · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327088724), received between Jun 21, 2018 and Aug 14, 2025 — classified as 3 injuries.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture2
Patient problems
- Failure of Implant2
- Injury1
- Insufficient Information1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE PLATE BROKE WITHOUT A FALL OR TRAUMA DESCRIBED BY THE PATIENT, WHICH RESULTED IN A REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 22803494 ↗InjuryDec 21, 2019Fracture; Fracture
1/3RD TUBULAR PLATE BROKE AT A SCREW HOLE. PATIENT WENT IN FOR A NORMAL POST OP CHECK UP ON 11/22 AND IT WAS NOTICED ON X RAY THAT THE PLATE STARTED TO CRACK. THE FOLLOWING DAY 11/23 THE PATIENT WENT BACK TO THE DOCTORS OFFICE BECAUSE SHE WAS IN SEVERE PAIN ON HER ELBOW WHERE THE IMPLANT WAS PUT. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant; Injury; Pain
MAUDE report 9508131 ↗InjuryJun 21, 2018Break
BROKEN PLATE HAD TO BE REPLACED. UPDATE FROM REP 6/14/18 MG: THE FIRST SURGERY WAS SUCCESSFUL THE PATIENT BROKE THE PLATE AT HOME AND THE SURGEON BROUGHT HIM BACK TO PUT A NEW PLATE ON.
Patient problems: Failure of Implant
MAUDE report 7627167 ↗
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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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