BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0001825034-2013-02664

    MDR report key: 3223789 · Received July 12, 2013

    Report

    Report Number
    0001825034-2013-02664
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBV
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A SURGICAL DELAY MAY HAVE OCCURRED; IT IS ALSO UNKNOWN WHICH SCREW THE SURGEON WAS UNABLE TO REMOVE. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. IT IS UNKNOWN WHICH OF THE FOLLOWING PRODUCTS WAS RETAINED BY THE PATIENT: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TIBIAL PLATING PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT UNDERWENT A PLATE REMOVAL PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, THE SURGEON WAS UNABLE TO REMOVE ONE OF THE SCREWS; IT IS UNKNOWN WHICH SCREW WAS NOT REMOVED. THE PATIENT RETAINED THE PLATE AS WELL AS THE SCREW. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321366 MBV BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R