BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SOURCE, HA CEMENT, 10 GM

    MDR report key: 106983 · Received July 18, 1997

    Report

    Report Number
    8010177-1997-00022
    Event Type
    Injury
    Date Received
    July 18, 1997
    Date of Event
    June 17, 1997
    Report Date
    July 17, 1997
    Manufacturer
    HOWMEDICA INC.
    Product Code
    GXP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH HOWMEDICA, INC IS A DIST OF THIS DEVICE, A MFR REPORT HAD INADVERTENTLY BEEN SUBMITTED FOR THIS COMPLAINT. THE ASSIGNED MFR REPORT # 8010177-1997-00022 WAS LEFT IN THIS REPORT FOR REFERENCE. THIS NUMBER WILL BE DELETED FROM HOWMEDICA'S FILE FOR THIS REPORT. DIST REPORT # 1643758-1997-00002 HAS BEEN ASSIGNED TO THIS FILE. SECTION F HAS BEEN UPDATED ACCORDINGLY. THIS REPORT HAS BEEN SENT TO THE MFR FOR APPLICABLE REPORTING REQUIREMENTS. THIS IS THE SAME PT/EVENT AS MFR #8010177-1997-00021 AND DIST REPORT #1643758-1997-00003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE SOURCE, HA CEMENT, 10 GM Implant OTHER GXP HOWMEDICA INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention