BEUDAMED
    FDA Adverse Event Summary report: N

    LOW PROFILE SCREW

    MDR report key: 2052133 · Received April 1, 2011

    Report

    Report Number
    2052133
    Date Received
    April 1, 2011
    Date of Event
    March 2, 2011
    Report Date
    April 1, 2011
    Manufacturer
    BIOMET
    Product Code
    LPH
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE OR WAS NOTIFIED OF THE BIOMET URGENT MEDICAL DEVICE RECALL OF CERTAIN LOW PROFILE SELF TAPPING BONE SCREWS. A LETTER FROM BIOMET ADVISED THAT THIS PATIENT HAD ONE OF THE RECALLED SCREWS, WHICH HAD BEEN IMPLANTED WEEKS PRIOR DURING HIP SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW PROFILE SCREW LOW PROFILE SELF-TAPPING SCREW LPH BIOMET 103533 502360

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR