BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON PUNCH 130DEG UP 200M 1MM THIN

    MDR report key: 3844771 · Received March 12, 2014

    Report

    Report Number
    2916714-2014-00126
    Event Type
    Malfunction
    Date Received
    March 12, 2014
    Date of Event
    January 22, 2014
    Report Date
    March 5, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    LRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR SITE EVAL: WAITING FOR PRODUCT TO BE RETURNED.

    Description of Event or Problem · 1

    FOOTPLATE BROKE OFF DURING A CERVICAL PROCEDURE. NO PT INJURY OR PROLONGING OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149247 KERRISON PUNCH 130DEG UP 200M 1MM THIN LRY AESCULAP AG & CO. KG FF661R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other