BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROLIFT VBR SZ.5 (40-60.5MM) /ENDPL.M

    MDR report key: 3881540 · Received May 28, 2014

    Report

    Report Number
    3005673311-2014-00055
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    MQP
    PMA / PMN Number
    K083186
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: EVALUATION IS ON-GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). IMPLANTATION ON (B)(6) 2014 RESULT SUFFICIENT. A FEW DAYS POST OP IT WAS NOTICED THE HYDROLIFT US SKEWED. PATIENT HAS SLIGHT OSTEOPOROSIS BUT NO IMPACT ON THE BASEPLATE. SURGEON REPLACED WITH A NEW CAGE WITH LARGER BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314514 HYDROLIFT VBR SZ.5 (40-60.5MM) /ENDPL.M VERTEBRAL BODY REPLACEMENT MQP AESCULAP AG & CO. KG SV014T 51746632

    Patients

    Seq Age Sex Outcome Treatment
    1 Other