BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANGEA PLATFORM LOCKING SCREW 5.0MM / T20 / L85MM

    MDR report key: 25255960 · Received May 22, 2026

    Report

    Report Number
    0008031020-2026-00687
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 22, 2026
    Manufacturer
    STRYKER GMBH
    Product Code
    HWC
    UDI-DI
    07613327414004
    PMA / PMN Number
    K242445
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON COMPLETION OF THE INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED: "PLATE LOCKING SCREWS BECAME PROMINENT AFTER THE LOCKING MECHANISM UNCOUPLED RESULTING IN A LACK OF STABILITY AND HWR SURGERY. A SINGLE DISTAL LATERAL LOCKING 5.0 SCREW WAS VISIBLE UNDERNEATH THE PLATE SURFACE CONFIRMING SCREW TEAR THRU THE LOCKING MECHANISM OF THE PLATE. UNUSUAL PERFORMANCE OF THE LOCKING PLATE WAS QUESTIONED BY THE SURGEON AND PATIENT WAS THEN STAGED WITH A STATIC SPACER WITH ANTIBIOTICS ON (B)(6) 2026 AND THEN A DFR SCHEDULED A FEW DAYS LATER. HOWEVER, BEFORE THE PATIENT'S DFR THEY PASSED AWAY FROM POST-SURGICAL COMPLICATIONS RELATED TO GENERAL HEALTH AND OPTIMIZATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364338 PANGEA PLATFORM LOCKING SCREW 5.0MM / T20 / L85MM SCREW, FIXATION, BONE HWC STRYKER GMBH UNKNOWN 07613327414004

    Patients

    Seq Age Sex Outcome Treatment
    1