BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRO LINK

    MDR report key: 5719030 · Received June 10, 2016

    Report

    Report Number
    3006108336-2016-00005
    Event Type
    Injury
    Date Received
    June 10, 2016
    Report Date
    June 1, 2016
    Manufacturer
    CAYENNE MEDICAL
    Product Code
    MBI
    PMA / PMN Number
    K122314
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANTED IMPLANT WAS NOT RETURNED.

    Description of Event or Problem · 1

    ON 05/04/2016, CAYENNE MEDICAL WAS NOTIFIED BY DR (B)(6) THAT HE HAD OBSERVED A LOOSE LATERAL QUATTRO LINK ANCHOR WITH HEALED ROTATOR CUFF TENDON, AND NOTABLE BURSITIS. HE HAD ALSO OBSERVED AN AUDIBLE AND PALPABLE "CLUNK" WITH ARM ROTATION DURING EXAMINATION. THE SURGEON REPORTED THAT THIS INCIDENT COULD BE DUE TO OPERATOR ERROR AND A SURGERY WAS PLANNED TO REMOVE THE QUATTRO LINK ANCHOR. ON 06/01/2016, CAYENNE MEDICAL RECEIVED FURTHER INFORMATION REGARDING THE SURGERY TO REMOVE THE QUATTRO LINK ANCHOR. IT WAS REPORTED THAT THE SURGEON REMOVED THE PROUD QUATTRO LINK IMPLANT WITHOUT INCIDENT. IT WAS ALSO REPORTED THAT THE ROTATOR CUFF HAD HEALED AT THE TIME OF SURGERY. THE SURGEON THINKS THAT THIS INCIDENT WAS DUE TO HIS TECHNIQUE SINCE HE DID NOT TIE OVER THE MEDIAL ROW ANCHORS, CHOOSING INSTEAD TO BRING THE SUTURES OUT LATERALLY FOR PLACEMENT INTO THE LINK ANCHOR, POSSIBLY LEADING TO MICRO MOTION OF THE LATERAL ROW ANCHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371493 QUATTRO LINK KNOTLESS SUTURE ANCHOR MBI CAYENNE MEDICAL UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention