BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BDRV CANN SCW SS P/T DIA4.5X52MM

    MDR report key: 6281448 · Received January 26, 2017

    Report

    Report Number
    0009610576-2017-00005
    Event Type
    Injury
    Date Received
    January 26, 2017
    Report Date
    January 26, 2017
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    HRS
    PMA / PMN Number
    PK092670
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    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. EXPIRATION DATE ¿ NI. DATE IMPLANTED ¿ NI. INITIAL REPORTER SURGEON ¿ NI. MANUFACTURE DATE ¿ NI. PMA 510(K): - 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 K092670. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 9610576-2017-00004 / 00005).

    Description of Event or Problem · 1

    PATIENT IS EXPERIENCING SYMPTOMS OF AN ALLERGIC REACTION TO THE IMPLANTED SCREWS. NO REVISION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64606 BDRV CANN SCW SS P/T DIA4.5X52MM FIXATION, PLATE HRS BIOMET SPAIN, S.L. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention