BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0 X 9MM SD IMF HEX SCREW

    MDR report key: 5434031 · Received February 12, 2016

    Report

    Report Number
    0001032347-2016-00084
    Event Type
    Injury
    Date Received
    February 12, 2016
    Date of Event
    January 13, 2016
    Report Date
    January 13, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    PK983728
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. BASED ON THE INFORMATION PROVIDED THERE IS NO INDICATION THE IMPLANTS WERE NOT FUNCTIONING AS INTENDED, THE IMPLANTS WERE EXPLANTED DUE TO THE PATIENT DEVELOPING HETEROTOPIC BONE GROWTH. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. DEVICE PRODUCT CODE IS DZL, REPORT FIVE OF SIX FOR THE SAME EVENT; SEE ALSO 0001032347-2016-00056, 0001032347-2016-00057, 0001032347-2016-00082 THROUGH 0001032347-2016-00085.

    Description of Event or Problem · 1

    THE SALES ASSOCIATED REPORTED A REVISION DUE TO HETEROTOPIC BONE GROWTH. THE IMPLANTS WERE REMOVED AND REPLACED WITH NEW IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91523 2.0 X 9MM SD IMF HEX SCREW SCREW HWC BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O