T2 ALPHA 2360-5037SRecalls & reported problems
Stryker GmbH · Locking Screw · Class 2 · Implant
All models of T2 ALPHA (123)
Data updated Oct 18, 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 07613327366150), received between Dec 15, 2020 and Jul 7, 2026 — classified as 3 injuries.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Insufficient Information2
- Limb Fracture1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 7, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT, POSTOPERATIVELY, THE DISTAL SCREW CAME LOOSE. A REVISION SURGERY WAS PERFORMED TO REPLACE THE NAIL WITH A LONG NAIL. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25734864 ↗InjuryMar 23, 2026Fracture
AS REPORTED: "IMN FEMUR WAS DONE ON (b)(6) 2025. THE DOCTOR SAW THE PATIENT IN THE CLINIC ON (b)(6) 2026 AND REPORTED THAT THE A/R NAIL IN THIS PATIENT WAS BENDING AFTER SEEING HIM IN CLINIC THIS WEEK. HE ALSO REPORTED THAT ONE OF THE LOCKING SCREWS IS ALSO BROKEN."
Patient problems: Insufficient Information; Nonunion/Delayed-union Bone Fracture
MAUDE report 24669651 ↗InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
TIBIAL FRACTURE REPAIR. CRACKS OCCUR AROUND THE SCREW DURING EXTERNAL COMPRESSION. IT WAS REVEALED AT THE TIME OF POSTOPERATIVE X-RAY PHOTOGRAPHY. THE SPLINT WAS FIXED AND UNLOADED.
Patient problems: Limb Fracture
MAUDE report 11008006 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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