PANGEA 541526Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327604610), received between Mar 31, 2025 and Mar 31, 2025 — classified as 1 injury.
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
- Failure of Implant1
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT PRESENTED IN ER FROM A GSW TO DISTAL HUMERUS ON (B)(6) 2024. TAKEN TO SURGERY FOR AN ORIF WITH PANGEA EXTRA-ARTICULAR HUMERAL PLATE AND VARIAX MINIFRAG. SURGERY WAS SUCCESSFUL WITH POST OP X-RAYS TO SHOW CORRECT ALIGNMENT AND UTILIZATION. PATIENT WAS DISCHARGED APPROPRIATELY BUT THEN GOT INTO MULTIPLE ALTERCATIONS (FIST FIGHTS) OVER THE FIRST FEW WEEKS' POST OP. PATIENT ALSO STATED HE MADE ATTEMPTS TO REMOVE HIS CAST AT HOME. HE ALSO TRIED TO START A PHYSICAL ALTERCATION WITH AN ORTHO PA AT HIS FOLLOW-UP APPOINTMENT. THE PATIENT WAS BROUGHT BACK TO SURGERY FOR A REVISION ON (B)(6) 2025. NO INFECTION WAS PRESENT. HARDWARE SHOWED SIGNS OF FAILURE WITH BROKEN PLATE, BROKEN SCREWS, AND A LOCKING HOLE FAILURE. APPEARS THE LOCKING SCREW MIGRATED THROUGH THE HOLE OF THE PLATE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 21734869 ↗
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- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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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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