NA 2361-5090SRecalls & reported problems
Stryker GmbH · Advanced Locking Screw · Class 2 · Implant
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 07613327381641), received between Dec 16, 2020 and May 5, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Break1
- Migration1
Patient problems
- Failure of Implant2
- Impaired Healing1
- 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.
InjuryMay 5, 2026Fracture
IT WAS REPORTED THAT TWO CONDYLE SCREWS AND ONE ADVANCED LOCKING SCREW BROKE. THERE WERE ADDITIONAL REPORTS OF A NON-UNION. THIS RESULTED IN A REVISION SURGERY.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 25079105 ↗InjurySep 15, 2023Break; Fracture; Break; Fracture
AS REPORTED: "T2 ALPHA FEMORAL RETROGRADE NAIL WAS FRACTURED AND DISTAL SCREWS WERE FRACTURED. ADVERSE CONSEQUENCES OF DELAYED FUSION AND REVISION SURGERY WERE REPORTED TOO."
Patient problems: Failure of Implant; Impaired Healing
MAUDE report 17760193 ↗InjuryDec 16, 2020Migration; Migration
SURGEON HAD A CASE WITH A T2 ALPHA ANTEGRADE FEMORAL NAIL WHERE TWO OF THE DISTAL TRANSVERSE SCREWS BACKED OUT APPROXIMATELY TWO WEEKS AFTER SURGERY. PATIENT RETURNED TO OPERATING ROOM FOR SURGICAL INTERVENTION.
Patient problems: Failure of Implant
MAUDE report 11020435 ↗
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- 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 STP3.5-400Nuvasive 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.
How reports and recalls are matched · Editorial policy · Report an error on this page