BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEG FULL THREAD 2.5X24MM

    MDR report key: 3911975 · Received July 3, 2014

    Report

    Report Number
    0001825034-2014-05865
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    January 9, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRS
    PMA / PMN Number
    PK111663
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION CONFIRMED THE PRODUCT IN THE PACKAGING WAS NOT THE ITEM ON THE LABEL. THERE WAS NO DAMAGE TO THE PACKAGING. IT WAS DETERMINED THE ITEM IN THE PACKAGING WAS MANUFACTURED ON THE SAME DAY AT THE SAME LOCATION. COMPLAINT HISTORY WAS REVIEWED FOR BOTH THE ITEM ON THE LABEL AS WELL AS THE ITEM IN THE PACKAGING AND NO COMPLAINTS WERE FOUND INVOLVING AN INCORRECT PRODUCT. IT WAS DETERMINED THIS IS AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE A PROCEDURE, IT WAS NOTICED THE SCREW IN THE PACKAGE DID NOT MATCH THE LABEL. THIS WAS NOTICED IN THE STERILIZATION DEPARTMENT. THERE WAS NO PATIENT OR SURGEON INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389385 PEG FULL THREAD 2.5X24MM PLATE, FIXATION, BONE HRS BIOMET ORTHOPEDICS N/A HMPBZV

    Patients

    Seq Age Sex Outcome Treatment
    1