BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSORB 1 PIN 50X1.3MM KIT

    MDR report key: 3144243 · Received June 4, 2013

    Report

    Report Number
    0001825034-2013-01784
    Event Type
    Injury
    Date Received
    June 4, 2013
    Date of Event
    April 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    BIOMET TRAUMA
    Product Code
    OVZ
    PMA / PMN Number
    PK111077
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A BUNIONECTOMY PROCEDURE UTILIZING A RESORBABLE PIN ON (B)(6) 2013. DURING THE PROCEDURE, THE PIN FRACTURED UPON INSERTION IN THE PATIENT AND THE SURGEON REMOVED PIECES OF THE PIN. ANOTHER PIN WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245715 ORTHOSORB 1 PIN 50X1.3MM KIT PIN, FIXATION OVZ BIOMET TRAUMA N/A 307074

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R