BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEG THREAD MULTIDIR 2.5X20MM

    MDR report key: 3041501 · Received April 8, 2013

    Report

    Report Number
    0001825034-2013-00884
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXT
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - N/A. DATE EXPLANTED - N/A. PMA/510(K) NUMBER / MANUFACTURE DATE - UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TRAUMA PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, THE SURGEON WAS NOT ABLE TO SEAT THE 20 MM SCREW PROPERLY. AS A RESULT, THE SURGEON REMOVED THE SCREW AND UTILIZED A 22MM SCREW TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143669 PEG THREAD MULTIDIR 2.5X20MM APPLIANCE, FIXATION LXT BIOMET ORTHOPEDICS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R