BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL CLAMP

    MDR report key: 2757542 · Received September 20, 2012

    Report

    Report Number
    3003853072-2012-00020
    Event Type
    Injury
    Date Received
    September 20, 2012
    Report Date
    August 21, 2012
    Manufacturer
    ZIMMER SPINE
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROD SNAPPED POST-OPERATIVELY. THE PATIENT HAD UNDERGONE 2 PREVIOUS REVISION SURGERIES. DETAILS UNSPECIFIED. THE ROD IS NOT THOUGHT TO BE A ZIMMER SPINE PRODUCT BASED ON THE COMPLAINT DESCRIPTION, BUT BECAUSE IT WAS REPORTED TO BE USED WITH A ZIMMER SPINE PRODUCT, THIS REPORT IS BEING SUBMITTED. NO DAMAGED OR MALFUNCTION OCCURRED WITH THE ZIMMER SPINE PRODUCT. THE MANUFACTURER OF THE ROD IS UNKNOWN AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ANY FURTHER RELEVANT INFORMATION WILL BE PROVIDED UPON RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL CLAMP UNIVERSAL CLAMP LXH ZIMMER SPINE SN2027-0-30055 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention