BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE BONE AWL

    MDR report key: 5248850 · Received November 25, 2015

    Report

    Report Number
    3005673311-2015-00177
    Event Type
    Malfunction
    Date Received
    November 25, 2015
    Report Date
    October 16, 2017
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    HWJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: ON-GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). DURING INTRA-OPERATIVE THE FLEXIBLE SEGMENT BROKEN AT BOTH ENDS. INDICATION: L5 / S1 BOTH ENDS OF THE FLEXIBLE MEMBERS ARE BROKEN - BUT NOT FALLEN OFF WITH THE BROKEN INSTRUMENT WAS OPERATED UP TO THE END. NO OPERATIVE TIME EXTENTION. NO OTHER PATIENT RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779636 FLEXIBLE BONE AWL SIBD LUMBAR INSTRUMENTS HWJ AESCULAP IMPLANT SYSTEMS SJ607R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other