PANGEA 662346Recalls & 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
- 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 07613327415902), received between Oct 3, 2025 and May 13, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (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
- Adverse Event Without Identified Device or Use Problem1
- Migration1
Patient problems
- Insufficient Information1
- Post Operative Wound Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem
AS REPORTED: "REVISED A LEFT HIP DUE TO INFECTION. REMOVED ALL HARDWARE AND REPLACED WITH A SERF NOVAE STICK CUP AND COMPETITOR STEM". NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Post Operative Wound Infection
MAUDE report 25166758 ↗InjuryOct 3, 2025Migration; Migration
AS REPORTED: "A PANGEA DISTAL FEMUR PLATE WAS PLACED ON (B)(6) 2025 THERE WAS A REVISION CASE DONE ON (B)(6) 2025 WHERE IT SHOWED MULTIPLE 5.0 LOCKING SCREWS GOING THROUGH THE PLATE HOLE. LATERAL X-RAY FROM THE PREVIOUS SURGERY SHOWED THAT THE SCREWS DIDN¿T MISS THE PLATE IN THE INITIAL SURGERY. THE PLATE MALFUNCTION RESULT IN A REVISION SURGERY WHERE MULTIPLE SCREWS WERE REMOVED FROM THE PLATE AND A RETROGRADE NAIL WAS PLACED."
Patient problems: Insufficient Information
MAUDE report 23213573 ↗
Other Screw, fixation, bone devices
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive 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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