BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAVICLE PIN ASSEMBLY 3.0MM

    MDR report key: 3002515 · Received March 13, 2013

    Report

    Report Number
    0001825034-2013-00590
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 15, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRS
    PMA / PMN Number
    PK111663
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. 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 ADVERSE EFFECTS, OT STATES, "THE FOLLOWING ARE THE MOST FREQUENT ADVERSE EVENTS AFTER FIXATION WITH BONE SCREWS OR PINS: LOOSENING, BENDING, CRACKING OR FRACTURE OF THE COMPONENTS OR LOSS OF FIXATION IN BONE ATTRIBUTABLE TO NONUNION, OSTEOPOROSIS, MARKEDLY UNSTABLE COMMINUTED FRACTURES; LOSS OF ANATOMIC POSITION WITH NONUNION OR MALUNION WITH ROTATION OR ANGULATION; INFECTION AND ADVERSE REACTIONS TO THE DEVICE MATERIAL."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN OPEN REDUCTION, INTERNAL FIXATION CLAVICLE PROCEDURE ON (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO THE ROCKWOOD CLAVICLE PIN BENT. THE PIN WAS REMOVED AND REPLACED WITH ANOTHER PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105211 CLAVICLE PIN ASSEMBLY 3.0MM PLATE, FIXATION HRS BIOMET ORTHOPEDICS N/A 264937

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R