PANGEA 662375Recalls & reported problems
Stryker GmbH · Locking Screw · Class 2 · Implant
All models of PANGEA (53)
Data updated Oct 16, 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 07613327414141), received between Aug 6, 2025 and Aug 7, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth3
- Migration3
Patient problems
- Insufficient Information3
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2025Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration
PANGEA 5.0MM LOCKING SCREWS BACKED OUT FROM THE PLATE AND BECAME PROMINENT REQUIRING HARDWARE REMOVAL SURGERY.
Patient problems: Insufficient Information
MAUDE report 22742411 ↗InjuryAug 7, 2025Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration
PANGEA 5.0MM LOCKING SCREWS BACKED OUT FROM THE PLATE AND BECAME PROMINENT REQUIRING HARDWARE REMOVAL SURGERY.
Patient problems: Insufficient Information; Pain
MAUDE report 22742353 ↗InjuryAug 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration
PANGEA 5.0MM LOCKING SCREWS BACKED OUT FROM THE PLATE AND BECAME PROMINENT REQUIRING HARDWARE REMOVAL SURGERY.
Patient problems: Insufficient Information
MAUDE report 22732526 ↗
Other Screw, fixation, bone devices
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- 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 STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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