BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA DRIVE 6MM PLUG PULLER

    MDR report key: 2625191 · Received June 21, 2012

    Report

    Report Number
    0001825034-2012-00895
    Event Type
    Injury
    Date Received
    June 21, 2012
    Date of Event
    May 9, 2012
    Report Date
    May 11, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JXE
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. THE APPROPRIATE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. DEVICE AVAILABILITY - THE REMAINING PORTION OF THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION PROCEDURE UTILIZING A PLUG PULLER ON (B)(6) 2012. DURING THE PROCEDURE, THE PLUG PULLER FRACTURED AND WAS LEFT IN THE PATIENT'S BONE. NO FURTHER INFORMATION WAS PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA DRIVE 6MM PLUG PULLER NERVE CONDUCTION VELOCITY MEASUREMENT DEVICE JXE BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability