BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSORB 1 PIN 50X1.3MM KIT

    MDR report key: 3778162 · Received April 29, 2014

    Report

    Report Number
    0001825034-2014-03339
    Event Type
    Injury
    Date Received
    April 29, 2014
    Report Date
    April 2, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    OVZ
    PMA / PMN Number
    PK111077
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A BUNION PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE THE ORTHOSORB PIN BROKE. A PIECE OF THE PIN FELL INTO THE PATIENT'S WOUND AND WAS RETRIEVED. ANOTHER ORTHOSORB PIN WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257166 ORTHOSORB 1 PIN 50X1.3MM KIT PIN, FIXATION, RESORBALE, HARD TISSUE OVZ BIOMET ORTHOPEDICS N/A 453618

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R