BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APERFIX

    MDR report key: 6734314 · Received July 21, 2017

    Report

    Report Number
    3006108336-2017-00005
    Event Type
    Injury
    Date Received
    July 21, 2017
    Date of Event
    November 21, 2016
    Report Date
    July 21, 2017
    Manufacturer
    CAYENNE MEDICAL, INC.
    Product Code
    HWC
    PMA / PMN Number
    K083612
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CAYENNE MEDICAL WAS NOTIFIED OF A COMPLAINT WHERE AN APERFIX IMPLANT HAD BACKED OUT OF FEMORAL TUNNEL. AFTER FOLLOW UP WITH THE SALES REPRESENTATIVE, IT WAS FOUND OUT THAT A FEW MONTHS AFTER THE ORIGINAL ACL RECONSTRUCTION PROCEDURE, THE SURGEON FOUND THE METAL SCREW INSIDE THE IMPLANT AT A DIFFERENT LOCATION ON X-RAY (CAYENNE DOES NOT KNOW WHETHER A POST-OP X-RAY WAS TAKEN AT THE TIME OF SURGERY). THE REPORT FROM SALES REPRESENTATIVE SAID THAT SHORTLY AFTER THAT FOLLOW UP, THE PATIENT CAME BACK DUE TO THE IMPLANT BACKING OUT COMPLETELY. A SECOND SURGERY, A REVISION, WAS THEN PERFORMED AND ANOTHER IMPLANT WAS USED TO RECONSTRUCT THE ACL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513675 APERFIX BONE SCREW HWC CAYENNE MEDICAL, INC. CM-2910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention