BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW CORTICAL 3.5X14MM

    MDR report key: 3250445 · Received July 26, 2013

    Report

    Report Number
    0001825034-2013-02951
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    June 27, 2013
    Report Date
    September 16, 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
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. LOT NUMBER AND EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02950 / 02951).

    Additional Manufacturer Narrative · 1

    DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A DISTAL RADIUS FIXATION PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE THE THREADS OF A CORTICAL SCREW AND PEG STRIPPED. BOTH THE SCREW AND PEG WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351517 SCREW CORTICAL 3.5X14MM PLATE, FIXATION HRS BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R