BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULATED PARTIALLY THREADED RECONSTRUCTIVE SCREW

    MDR report key: 2490281 · Received March 13, 2012

    Report

    Report Number
    0001825034-2012-00248
    Event Type
    Injury
    Date Received
    March 13, 2012
    Date of Event
    February 11, 2012
    Report Date
    February 14, 2012
    Manufacturer
    BIOMET
    Product Code
    HSB
    PMA / PMN Number
    PK063570
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER TWO STATES, "BENDING OR FRACTURE OF THE IMPLANT." THE 510K - COULD INSTEAD BE K072161.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE TO FIX A FEMORAL MIDSHAFT FRACTURE ON (B)(6) 2011. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012, DUE TO A DISTAL CANNULATED PARTIALLY THREADED RECONSTRUCTIVE SCREW FRACTURING, WHICH ALSO CAUSED ANOTHER RECONSTRUCTIVE SCREW TO MIGRATE OUT OF POSITION. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED PARTIALLY THREADED RECONSTRUCTIVE SCREW ROD, FIXATION HSB BIOMET N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R