BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BDRV CANN SCW SS P/T DIA4.5X52 MM

    MDR report key: 6384991 · Received March 7, 2017

    Report

    Report Number
    0009610576-2017-00009
    Event Type
    Injury
    Date Received
    March 7, 2017
    Report Date
    March 5, 2017
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    HWC
    PMA / PMN Number
    PK140891
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT ¿ NI, EXPIRATION DATE ¿ NI, DATE IMPLANTED ¿ NI, MANUFACTURE DATE ¿ NI. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET US AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K140891. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 9610576-2017-00008 / 00009).

    Description of Event or Problem · 1

    PATIENT HAS ALLEGED AN ALLERGY TO THE CANNULATED TRAUMA SCREWS IMPLANTED DURING A FOOT OSTEOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168247 BDRV CANN SCW SS P/T DIA4.5X52 MM FASTENER, FIXATION HWC BIOMET SPAIN, S.L. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other