BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMMA4 - LAG SCREW D10.5X80MM

    MDR report key: 22327155 · Received June 25, 2025

    Report

    Report Number
    0008031020-2025-01009
    Event Type
    Injury
    Date Received
    June 25, 2025
    Date of Event
    March 10, 2025
    Report Date
    June 25, 2025
    Manufacturer
    STRYKER GMBH
    Product Code
    HSB
    UDI-DI
    07613327511079
    PMA / PMN Number
    K213328
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WERE PROVIDED. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    SUBJECT: 002-042. STRYKER PEGASUS STUDY. (B)(6) 2025. NON-UNION (NO BONE CONSOLIDATION WITHIN 6MONTHS). XRAYS TAKEN ON (B)(6) 2025 SHOW THAT BONE IS NOT HEALED. FOLLOW-UP BLOOD TESTS AND CT SCAN ORDERED. PLAN FOR PATIENT TO RETURN TO CLINIC IN THREE WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2485245 GAMMA4 - LAG SCREW D10.5X80MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER GMBH K199567 07613327511079

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other