PANGEA 662350Recalls & 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 07613327416015), received between Oct 3, 2025 and Oct 3, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (2 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
- Migration2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 23211620 ↗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 23211612 ↗
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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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