T2 ALPHA 2360-5042SRecalls & reported problems
Stryker GmbH · Locking Screw · Class 2 · Implant
All models of T2 ALPHA (123)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327366136), received between Apr 21, 2022 and Sep 3, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Fracture1
- Material Twisted/Bent1
Patient problems
- Pain2
- Insufficient Information1
- Nonunion/Delayed-union Bone Fracture1
- Thrombosis/Thrombus1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 3, 2025Break; Fracture; Break; Fracture
AS REPORTED BY THE REP: "DATE OF ORIGINAL FIX (B)(6) 2024. DATE OF IMPLANT FAILURE (B)(6) 2025. PLANNED FOR REVISION. IMPLANTS WILL BE RETURNED. (B)(6) HOSPITAL (B)(6) FOR PRIMARY AND REVISION SURGERY." FURTHER INFORMATION FROM REP: "NO EVENTS AS SUCH, PRESENTED WITH HIP PAIN. NO FALL AS FAR AS WE KNOW. "
Patient problems: Nonunion/Delayed-union Bone Fracture; Pain
MAUDE report 22950444 ↗InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "SUBJECT: (B)(4). STRYKER PEGASUS STUDY. DEEP VEIN THROMBOSIS ACUTE DVT (LEFT PERONEAL VEIN) DIAGNOSE DATED ON (B)(6) 2023 AFTER A FEW DAYS OF WORSENING LEG SWELLING AND PAIN. DIAGNOSIS VIA ULTRASOUND. PATIENT MEDICATION CHANGED FROM HEPARIN TO ELIQUIS AND DISCHARGED SAME DAY. BY ORTHOPEDIC F/U ON (B)(6) 2023 PATIENT WAS SYMPTOM-FREE."
Patient problems: Pain; Thrombosis/Thrombus
MAUDE report 21993357 ↗MalfunctionApr 21, 2022Material Twisted/Bent; Material Twisted/Bent
AS REPORTED: "DURING THE EXTERNAL APPOSITION/COMPRESSION PROCEDURE FOR T2 ALPHA TIBIA NAIL, THE 42.5 MM LOCKING SCREW THAT HAD BEEN INSERTED INTO THE PROXIMAL OVAL HOLE WAS BENT. SCREW REMOVAL WAS POSSIBLE, BUT THE OPERATION TIME WAS PROLONGED BY 30 MINUTES."
Patient problems: Insufficient Information
MAUDE report 14165797 ↗
Other Screw, fixation, bone devices
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- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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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