BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5MM TI CANCELLOUS LOCKING SCREW 26MM THRD LENGTH

    MDR report key: 1022549 · Received March 27, 2008

    Report

    Report Number
    2530088-2008-00011
    Event Type
    Injury
    Date Received
    March 27, 2008
    Report Date
    March 3, 2008
    Manufacturer
    SYNTHESBRANDYWINE
    Product Code
    HWC
    PMA / PMN Number
    K022971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION DRAWN, AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    ADVERSE EVENT DUE TO REQUIRED INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5MM TI CANCELLOUS LOCKING SCREW 26MM THRD LENGTH CANCELLOUIS LOCKING SCREW HWC SYNTHESBRANDYWINE NA 5033632

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PLATE