BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI-SCREW FULL THD 6 X 60

    MDR report key: 5217825 · Received November 11, 2015

    Report

    Report Number
    0001825034-2015-04625
    Event Type
    Injury
    Date Received
    November 11, 2015
    Date of Event
    October 19, 2015
    Report Date
    October 14, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSB
    PMA / PMN Number
    PK982953
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. DATE EXPLANTED - BETWEEN SEPTEMBER 10, 1996 AND OCTOBER 19, 2015 THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-04624 / 04625).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 1996. DURING THE PROCEDURE, A FEMORAL NAIL AND THREE SCREWS WERE IMPLANTED IN THE LEFT LEG TO CORRECT A FRACTURE. SUBSEQUENTLY, PATIENT UNDERWENT A PROCEDURE TO REMOVE THE SCREWS ON AN UNKNOWN DATE BETWEEN SEPTEMBER 10, 1996 AND OCTOBER 19, 2015. SUBSEQUENTLY, PATIENT UNDERWENT ANOTHER PROCEDURE ON (B)(6) 2015. DURING THE PROCEDURE, THE NAIL AND PROXIMAL SCREW WERE REMOVED TO ALLOW FOR PROPER INSERTION OF A HIP PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748259 TI-SCREW FULL THD 6 X 60 ROD, FIXATION HSB BIOMET ORTHOPEDICS N/A 808420

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R