BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIO-PUSHLOCK 3.5MM X 14MM

    MDR report key: 1051785 · Received May 22, 2008

    Report

    Report Number
    1220246-2008-00098
    Event Type
    Other
    Date Received
    May 22, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 30, 2008
    Manufacturer
    ARTHREX INC.
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL AND THE CUSTOMER'S COMPLAINT COULD NOT BE VERIFIED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, A DEVICE HISTORY RECORD COULD NOT BE PERFORMED. THE CAUSE OF THE COMPLAINANT'S EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE AND WITHOUT DEVICE EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUTURES PULLED OUT AFTER INSERTING THE EYELET AND ANCHORS. THE ANCHORS WERE FULLY SEATED AND WERE LEFT IN PLACE. THE SURGERY WAS DELAYED OVER 30 MINUTES BUT NO ADDITIONAL ADVERSE CONSEQUENCES WERE REPORTED FROM THIS EVENT. NO FURTHER PT INFO IS AVAILABLE FROM THE CUSTOMER. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-PUSHLOCK 3.5MM X 14MM BIO-ABSORBABLE IMPLANT MAI ARTHREX INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other