NA 2361-5052SRecalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327381696), received between Apr 25, 2024 and Aug 25, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Malposition of Device1
- Material Protrusion/Extrusion1
- Mechanical Jam1
Patient problems
- Failure of Implant1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
AS REPORTED: "THE FRACTURE HAS VARUS AND THE DISTAL ADVANCE LOCKING SCREW HAS COME OUT." THE PATIENT EXPERIENCED PAIN. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. THE NAIL WAS REPLACED.
Patient problems: Pain
MAUDE report 22885588 ↗InjuryApr 25, 2024Malposition of Device; Material Protrusion/Extrusion; Mechanical Jam; Malposition of Device; Material Protrusion/Extrusion; Mechanical Jam
AS REPORTED: "ADVANCED LOCKING SCREW BOUND UP IN ALPHA TIBIA NAIL. WOULD NOT ADVANCE OR BACK UP. CUT SCREW TIP WITH BOLT CUTTER. SCREW PROMINENT. MAY NEED ADDITIONAL SURGERY TO REMOVE. REVISION SURGERY IS PLANNED, BUT NOT YET SCHEDULED. BONE QUALITY SEEMED NORMAL. THE LOCKING SCREW WAS PLACED IN THE PROXIMAL, OBLIQUE HOLE OF THE JIG AND INTO THE NAIL."
Patient problems: Failure of Implant
MAUDE report 19188049 ↗
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- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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- 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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