BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASPAR DISTR PIN12MMSTER

    MDR report key: 3944671 · Received April 16, 2014

    Report

    Report Number
    3005673311-2014-00038
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    December 26, 2013
    Report Date
    April 15, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: EVALUATION ONGOING AT MANUFACTURING SITE. POST OPERATIVE IMAGES HAVE BEEN RECEIVED FOR REVIEW.

    Description of Event or Problem · 1

    DURING ANTERIOR CERVICAL DISCECTOMY WITH FUSION, A 12MM CASPAR PIN FRACTURED IN VERTEBRAL BODY AT C5. UPON REMOVAL OF CASPAR PIN (DISTRACTING PIN), PIN FRACTURED, RETAINING A GOOD PORTION OF PIN WITHIN VERTEBRAL BODY. THIS WAS CONFIRMED WITH FLUOROSCOPY VISUALIZATION. THE SURGEON WAS UNABLE TO RETAIN THE FRACTURED PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233773 CASPAR DISTR PIN12MMSTER CERVICAL STABILIZATION DEVICE LXH AESCULAP AG & CO. KG FF912SB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other