T2 ALPHA 2360-5060SRecalls & 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
- 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 07613327368574), received between Jun 7, 2021 and Jul 10, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 10, 2026Fracture
AS REPORTED: "THE CUSTOMER REPORTED MEDIAL MIGRATION OF THE LAG SCREW IN A LEFT GAMMA 4 NAIL. THE PATIENT HAS BEEN REVISED." UPDATE (B)(6) 2026: "A BROKEN DISTAL SCREW WAS NOTICED TOO."
Patient problems: Insufficient Information
MAUDE report 25782917 ↗MalfunctionJun 7, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
AS REPORTED: SCREW IN INCORRECT PACKAGING. ADVANCED LOCKING SCREW - IN LOCKING SCREW PACKAGING. UPDATED INFORMATION: THE SURGEON WAS SCREWING THE SCREW INTO A T2 RECON FEMORAL NAIL. THE SURGEON COULDN¿T GET IT TO SCREW IN. THEY THEN SAW ON X-RAY THAT IT MIGHT BE AN ADVANCED LOCKING SCREW. THE SCREW WAS THEN REMOVED WHICH PROVED IT WAS AN ADVANCED LOCKING SCREW. THE SCREW WAS SEALED IN THE PICTURED PACKAGING BEFORE OPENING AND INSERTING. ANOTHER SCREW WAS OPENED AND USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11952646 ↗
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- 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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