BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIV C IMPLANT FLAT SIZE XXL 5MM

    MDR report key: 7232635 · Received January 31, 2018

    Report

    Report Number
    9610612-2018-00029
    Event Type
    Malfunction
    Date Received
    January 31, 2018
    Report Date
    February 21, 2018
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    LYQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    (B)(6). THE FIRST PROSTHESIS WAS NOT PROPERLY STORED IN THE PACKAGING. BOTH PARTS CRANIAL/CAUDAL WERE NOT IN THE DESIGNATED RECEPTACLE (INNER PACKAGING). WHEN IMPLANTED INTO THE INTERVERTEBRAL SPACE, THE IMPLANT WAS TOO LOOSE ON THE INSERT INSTRUMENT AND DISLODGED/DISPLACED WHEN INSERTED INTO THE INTERVERTEBRAL SPACE AND WAS ALSO REMOVED. THE SECOND IMPLANT WAS THEN OPENED AND IT WAS IMMEDIATELY SEEN THAT IN THE INNER PACKAGING BOTH PARTS WERE NOT IN THE DESIGNATED RECEPTACLE. THEREAFTER, THE NEXT SIZE WAS TAKEN, BUT THE BONE OR THE INTERVERTEBRAL SPACE HAD TO BE FURTHER MILLED TO FIT THIS SIZE. SURGERY DELAY APPROX. 40 MIN. COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: SW299K / ACTIV C IMPLANT FLAT SIZE XXL 5MM, FW863R / ACTIV C SPACER H5MM.

    Additional Manufacturer Narrative · 1

    (B)(4). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: IT WAS INITIALLY REPORTED THIS COMPLAINT SHOULD NOT HAVE BEEN REPORTED, THIS DEVICE WAS NOT MARKETED IN UNITED STATES. NO ADDITIONAL FOLLOW UP WILL BE FILED RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76106 ACTIV C IMPLANT FLAT SIZE XXL 5MM ACTIV C IMPLANTS LYQ AESCULAP IMPLANT SYSTEMS SW299K 51951682

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FW863R / ACTIV C SPACER H5MM| SW299K / ACTIV C IMPLANT FLAT SIZE XXL 5MM