TRIAX 5150-2-411Recalls & reported problems
Stryker GmbH · Carbon Tube; Blue · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327078978), received between Jun 29, 2020 and Jun 29, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Device Slipped” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Slipped1
Patient problems
- Injury1
- Malunion of Bone1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 29, 2020Device Slipped; Device Slipped
AS REPORTED: AFTER APPLICATION OF A BLUE TRIAX (FEMUR, CHILD) WITH CARBON ROD AND TWO 4-PIN HOLDERS, A PIN HOLDER ON THE ROD SHIFTED BECAUSE IT WAS LOOSENED AND THE FRACTURE HEALED WITH A MALPOSITION. ADDITIONALLY REPORTED: REVISION SURGERY NECESSARY WITH PLATE OSTEOTOMY.
Patient problems: Injury; Malunion of Bone
MAUDE report 10208486 ↗
Other COMPONENT, TRACTION, INVASIVE devices
- HOFFMANN 4940-1-020Stryker GmbH · COMPONENT, TRACTION, INVASIVE1 recall1 report
- NA 03.306.002Synthes GmbH · COMPONENT, TRACTION, INVASIVE5 reports
- NA 03.306.003Synthes GmbH · COMPONENT, TRACTION, INVASIVE5 reports
- NA 03.306.001Synthes GmbH · COMPONENT, TRACTION, INVASIVE4 reports
- NA 03.306.000Synthes GmbH · COMPONENT, TRACTION, INVASIVE2 reports
- BREMER 3D HALO CROWN 292301001Depuy Spine, LLC · COMPONENT, TRACTION, INVASIVE2 reports
- PIP Fix PFX-426Hand Biomechanics Lab Inc · Component, Traction, Invasive1 report
- DISTRACTION, INTERNAL 26-706-23-09KLS-Martin L.P. · COMPONENT, TRACTION, INVASIVE1 report
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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