NA 2361-5055SRecalls & reported problems
Stryker GmbH · Advanced Locking Screw · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327381610), received between Feb 21, 2025 and Nov 24, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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
- Loosening of Implant Not Related to Bone-Ingrowth1
- Mechanical Jam1
- Migration1
- Positioning Failure1
Patient problems
- Inadequate Osseointegration1
- 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.
MalfunctionNov 24, 2025Positioning Failure; Mechanical Jam; Positioning Failure; Mechanical Jam
AS REPORTED: "WHEN INSERTING THE DISTAL ADVANCE LOCKING SCREW, THE DISTAL TARGETING DEVICE WAS LOOSE, AND THE SCREW WAS DRIVEN IN AT AN INCORRECT ANGLE BEYOND THE ACCEPTABLE INSERTION RANGE. AS A RESULT, THE SCREW BECAME STUCK WITH THE NAIL AND COULD NOT BE REMOVED. ALTHOUGH IT WAS EVENTUALLY EXTRACTED WITH EFFORT, THE PRODUCTS WERE DAMAGED." 11/06/2025 - ADDITIONAL INFORMATION RECEIVED: HOW WAS THE ISSUE SOLVED? LONGER SCREW DRIVER WAS USED AS AN ALTERNATIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23632952 ↗MalfunctionFeb 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration
AS REPORTED: "ALS IS GRADUALLY LOOSENING UP AFTER SURGERY".
Patient problems: Inadequate Osseointegration; Insufficient Information
MAUDE report 21439249 ↗
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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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