NA 2361-5060SRecalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327381542), received between Apr 29, 2021 and Oct 16, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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
- Device Difficult to Setup or Prepare1
- Migration1
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
- 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.
MalfunctionOct 16, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
AS REPORTED: "THE HEXAGONAL HEAD OF THE ADVANCED LOCKING SCREW WAS MISSING SO THAT THE DRIVER COULD NOT BE USED. THE SURGEON USED ANOTHER ADVANCED LOCKING SCREW AND FINISHED OPERATION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23318635 ↗InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "ORIF WAS PERFORMED FOR FEMORAL CONDYLE FRACTURE ON (B)(6)2024. HOWEVER, IT WAS FOUND THAT FIXATION WAS NOT ACHIEVED ON (B)(6) 2024. THUS, REVISION SURGERY TO REMOVE THE DEVICES WAS PERFORMED ON (B)(6), 2024. THE DOCTOR TOLD THAT THE ORIGINAL FRACTURE WAS SEVERE, AND ALTHOUGH THE DEVICES WERE IMPLANTED IN HOPES OF REDUCING AND MAINTAINING THE FRACTURE, THE FRACTURE PART REMAINED UNSTABLE AFTER SURGERY."
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 19026644 ↗MalfunctionApr 29, 2021Migration; Migration
IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT WAS OPERATED WITH T2 ALPHA FEMORAL GT NAILS AND THE ADVANCED LOCKING SCREW BACKED OUT AFTER SURGERY. IT IS CURRENTLY UNDER FOLLOW-UP, BUT IF IT COMES OUT ANY MORE, THE DOCTOR WILL CONSIDER RE-OPERATION.
Patient problems: Failure of Implant
MAUDE report 11750817 ↗
Other Screw, fixation, bone devices
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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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