PANGEA 662250Recalls & reported problems
Stryker GmbH · Locking Screw · Class 2 · Implant
All models of PANGEA (53)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327414226), received between Mar 31, 2026 and Mar 31, 2026 — classified as 1 malfunction.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Difficult to Setup or Prepare1
- Malposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2026Device Difficult to Setup or Prepare; Malposition of Device
DR.(B)(6) REPORTED THE FEEDBACK ON HIS SECOND CASE, IN WHICH HE IMPLANTED A DISTAL MEDIAL FEMUR STRUT AND A DISTAL LATERAL FEMUR STRUT (DUAL-PLATE CONSTRUCT) IN PRESENCE OF PROSTHESES IN BOTH THE HIP AND THE KNEE JOINTS (MANUFACTURER(S) OF PROSTHESES UNKNOWN) HIS FEEDBACK ON EVALUATED ASPECTS IS ALL POSITIVE AND THE FOLLOWING COMMENTS WERE INCLUDED IN THE SUBMITTED FORM: "THE 4.0 LOCKING SCREWS WERE DIFFICULT TO LOCKING INTO THE PLATE AT A VARIABLE ANGLE. THIS HAS BEEN ANISSUE IN THE PAST WITH THE 4.0 LOCKING SCREWS IN OTHER PANGEA LARGE FRAG PLATES ALSO." [PROVIDED AS AN ADDITIONAL COMMENT ON THE PRODUCT AND PROCEDURE]
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24739675 ↗
Other Screw, fixation, bone devices
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- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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