PANGEA 540530Recalls & reported problems
Stryker GmbH · Distal Anterolateral Tibia Plate, R · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327611748), received between Oct 16, 2025 and Dec 1, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Malposition of Device” (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
- Malposition of Device1
- Positioning Failure1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED VIA MEDWATCH: MW5177124 "PROVIDER FEELS THERE IS A DESIGN FLAW IN PLATE- IF NOT LINED UP PERFECTLY SCREWS CANNOT BE THREADED AS INTENDED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23688255 ↗InjuryOct 16, 2025Malposition of Device; Malposition of Device
AS REPORTED: "THE SURGEON WAS USING PLATE 540530 (RIGHT 10 HOLE PANGEA DISTAL ANTEROLATERAL PLATE) WHEN THE INCIDENT OCCURRED. THE HE DRILLED THE HOLE USING THE VARIABLE ANGLE DRILL GUIDE. ONCE HE PLACED THE SCREW, IT WENT BELOW THE SCREW HOLE (3.5 LOCKING SCREW IN A 3.5MM HOLE) AND BECAME STUCK. HE TRIED MULTIPLE TIMES TO REMOVE THE SCREW, BUT UNFORTUNATELY WAS UNABLE. HE ENDED UP HAVING TO USE THE MIDAS REX TO REMOVE THE SCREW.".
Patient problems: Insufficient Information
MAUDE report 23317239 ↗
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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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