BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BDRV CANN SCW SS P/T DIA4.5X60MM

    MDR report key: 6281439 · Received January 26, 2017

    Report

    Report Number
    0009610576-2017-00004
    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. 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)(6) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K092670. THIS REPORT IS NUMBER 1 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
    64602 BDRV CANN SCW SS P/T DIA4.5X60MM FIXATION, PLATE HRS BIOMET SPAIN, S.L. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other