PANGEA 540182Recalls & reported problems
Stryker GmbH · Distal Lateral Femur Plate, R · Class 2 · Implant
All models of PANGEA (53)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327609783), received between May 22, 2026 and May 22, 2026 — classified as 1 death.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMay 22, 2026Device Dislodged or Dislocated
IT WAS REPORTED: "PLATE LOCKING SCREWS BECAME PROMINENT AFTER THE LOCKING MECHANISM UNCOUPLED RESULTING IN A LACK OF STABILITY AND HWR SURGERY. A SINGLE DISTAL LATERAL LOCKING 5.0 SCREW WAS VISIBLE UNDERNEATH THE PLATE SURFACE CONFIRMING SCREW TEAR THRU THE LOCKING MECHANISM OF THE PLATE. UNUSUAL PERFORMANCE OF THE LOCKING PLATE WAS QUESTIONED BY THE SURGEON AND PATIENT WAS THEN STAGED WITH A STATIC SPACER WITH ANTIBIOTICS ON (B)(6) 2026 AND THEN A DFR SCHEDULED A FEW DAYS LATER. HOWEVER, BEFORE THE PATIENT'S DFR THEY PASSED AWAY FROM POST-SURGICAL COMPLICATIONS RELATED TO GENERAL HEALTH AND OPTIMIZATION."
Patient problems: Insufficient Information
MAUDE report 25255962 ↗
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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