BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR IMPLANT LOCKING SCREW

    MDR report key: 3140751 · Received May 31, 2013

    Report

    Report Number
    0001825034-2013-01769
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWI
    PMA / PMN Number
    PK051385
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, IT STATES, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS. MALALIGNMENT OF THE COMPONENTS OR INACCURATE IMPLANTATION CAN LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE IMPLANT OR PROCEDURE."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RADIAL HEAD REPLACEMENT PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE AS THE SURGEON IMPLANTED THE SCREW INTO THE RADIAL HEAD, THE SCREW HEAD FRACTURED. THE SURGEON REMOVED THE HEAD AND THE FRACTURED SCREW. ANOTHER SCREW WAS OPENED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241633 EXPLOR IMPLANT LOCKING SCREW PROSTHESIS, ELBOW KWI BIOMET ORTHOPEDICS N/A 790650

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R