BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUP INSERTION INSTR. W/ THREAD M8X1 CVD

    MDR report key: 3941418 · Received April 16, 2014

    Report

    Report Number
    3005673311-2014-00039
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Report Date
    April 15, 2014
    Manufacturer
    AESCULAP AG AND CO. KG
    Product Code
    JDI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING AT MANUFACTURING SITE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE SCREW OF THE NT411R BROKE OFF INTRA-OPERATIVE. THE SCREW WAS RETRIEVED IMMEDIATELY. NO HARM TO PATIENT, NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232617 CUP INSERTION INSTR. W/ THREAD M8X1 CVD SPECIAL INSTR FOR HIP ENDOPROSTHETIC JDI AESCULAP AG AND CO. KG NT411R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other