BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON BLK COATED 130 UP 230X3MM THIN

    MDR report key: 4084980 · Received September 4, 2014

    Report

    Report Number
    2916714-2014-00702
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 5, 2014
    Report Date
    September 4, 2014
    Manufacturer
    AESCULAP AG AND CO. KG
    Product Code
    GXJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014; EVALUATION IS ONGOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: UNITED STATES; COMPLAINT STATES: 3MM KERRISON JAMMED INTO A PATIENT DURING SURGERY AND BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539456 KERRISON BLK COATED 130 UP 230X3MM THIN BONE PUNCH GXJ AESCULAP AG AND CO. KG FK926B 2692

    Patients

    Seq Age Sex Outcome Treatment
    1 Other