PANGEA 540834SRecalls & reported problems
Stryker GmbH · Extra Articular Distal Humerus 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
- 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 07613327622539), received between Jan 13, 2026 and Jan 13, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 Difficult to Setup or Prepare1
- Malposition of Device1
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.
InjuryJan 13, 2026Device Difficult to Setup or Prepare; Malposition of Device
AS REPORTED: "A REVISION SURGERY HAD TO BE PERFORMED USING SYNTHES. THE PATIENT HAD TO HAVE ANOTHER SURGERY. THE PLATE FAILED ACCORDING TO SURGEON AND A LOCKING SCREW PULLED THROUGH THE PANGEA DISTAL HUMERUS PLATE. A SYNTHES PLATE WAS USED FOR THE REVISION".
Patient problems: Insufficient Information
MAUDE report 24051328 ↗
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- PRECICE® Plating System LP4.5-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-PRT42Nuvasive Specialized Orthopedics, Inc. · Plate, 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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