BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEDGELOC 180X SUTURE ANCHOR

    MDR report key: 2259398 · Received August 31, 2011

    Report

    Report Number
    3007593722-2011-00001
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 30, 2011
    Manufacturer
    MEDSHAPE SOLUTIONS INCORPORATED
    Product Code
    MBI
    PMA / PMN Number
    K092914
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED FROM THIS INCIDENT. THE DEVICE WAS REQUESTED FOR EVALUATION, BUT WAS NOT RETURNED, THEREFORE, A DEVICE DEFECT COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW REVEALED THAT THE LOT WAS PRODUCED TO SPECIFICATIONS WITH NO ISSUES. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE INCIDENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    A PT HAD TWO 2.5MM MORPHIX DEVICES IMPLANTED IN (B)(6) 2011. SOMETIME POST-OPERATIVELY, THE PT FELT PAIN. DURING REVISION SURGERY, THE PHYSICIAN DISCOVERED ONE HAD PULLED OUT IN A FULLY-DEPLOYED POSITION. A DIFFERENT ANCHOR TYPE WAS THEN INSERTED IN THE SAME HOLE WITH SOLID FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WEDGELOC 180X SUTURE ANCHOR SOFT TISSUE FIXATION DEVICE MBI MEDSHAPE SOLUTIONS INCORPORATED 1000-03-225 50002

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other