BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSPACE PEEK IMPLANT 5 7X8X22MM

    MDR report key: 3196058 · Received June 21, 2013

    Report

    Report Number
    3005673311-2013-00085
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 9, 2013
    Report Date
    June 19, 2013
    Manufacturer
    AESCULAP AG AND CO. KG
    Product Code
    MAX
    PMA / PMN Number
    NARRATIVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN RECEIVED AT THE MANUFACTURING SITE; EVALUATION IS ON-GOING. 510 (K): K060762 AND K071983.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE SURGEON ATTEMPTED TO INSERT THE PROSPACE PEEK USING AN INSERTER. BECAUSE THE INTRAVERTEBRAL SPACE (L4/L5) WAS RELATIVELY NARROW, THE SURGEON HAD DIFFICULTY IN INSERTION OF THE CAGE, AND HE POUNDED THE INSERTER WITH A HAMMER FOR INSERTION OF THE CAGE. THE CAGE BROKE INSIDE THE INTRAVERTEBRAL SPACE AS A RESULT. THERE WAS EXTENDED TIME OF OPERATION OF APPROX 15 MIN FOR REMOVAL OF THE CAGE AND ITS PIECES. THE SURGEON WAS UNABLE TO FURTHER WIDEN THE INTERVERTEBRAL SPACE, THEREFORE, GAVE UP PLACING THE CAGE AND FINISHED THE PROCEDURE WITH BONE GRAFTING. THE BROKEN CAGE IS AVAILABLE FOR ANALYSIS. IT IS BROKEN AT WHERE INSERTER IS ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283010 PROSPACE PEEK IMPLANT 5 7X8X22MM MAX/ MQP MAX AESCULAP AG AND CO. KG SJ254P 51734854

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other