BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL CLAMP GENERIC

    MDR report key: 4234423 · Received October 31, 2014

    Report

    Report Number
    3003853072-2014-00036
    Event Type
    Injury
    Date Received
    October 31, 2014
    Report Date
    October 5, 2014
    Manufacturer
    ZIMMER SPINE
    Product Code
    OWI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS: 3003853072-2014-00035. INFO RECEIVED FROM JOURNAL ARTICLE. PT UNDERWENT SURGERY THEN EXPERIENCED IMPLANT-RELATED COMPLICATIONS WITH DEVELOPMENT OF AN ASEPTIC SOFT TISSUE REACTION WITH GRANULOMAS ADJACENT TO THE SUBLAMINAR POLYETHYLENE TEREPHTHALATE STRAPSETITANIUM CLAMP MECHANISM OF THE DEVICE 8 MONTHS AFTER AIS CORRECTION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698522 UNIVERSAL CLAMP GENERIC UNIVERSAL CLAMP GENERIC OWI ZIMMER SPINE SN2027 UNIVERSAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention