BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIARTICULAR CORTICAL SELF-TAPPING BONE SCREW

    MDR report key: 6116739 · Received November 21, 2016

    Report

    Report Number
    0002648920-2016-03285
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    July 29, 2016
    Report Date
    November 16, 2016
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    HWC
    PMA / PMN Number
    PK111447
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL BE REPORTED ON 0001822565-2017-01307.

    Description of Event or Problem · 1

    IT IS REPORTED THAT UPON REMOVAL OF THE PERIARTICULAR SCREW PROSTHESIS, BLACK CORROSION COULD BE FOUND ON THE SCREW THREADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768498 PERIARTICULAR CORTICAL SELF-TAPPING BONE SCREW TRAUMA PROSTHESIS HWC ZIMMER MANUFACTURING B.V. NA 63001753

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R