BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRD SPINE

    MDR report key: 4387771 · Received November 24, 2014

    Report

    Report Number
    4387771
    Event Type
    Injury
    Date Received
    November 24, 2014
    Date of Event
    January 15, 2013
    Report Date
    November 18, 2014
    Manufacturer
    LDR SPINE
    Product Code
    OVD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT CALLED ON (B)(6) 2014 TO ASK THAT WE PRESERVE THE HARDWARE WHICH WAS TO BE REMOVED ON (B)(6) 2014. THE HARDWARE WAS ORIGINALLY PLACED ON (B)(6) 2013. HE FELT THAT THE HARDWARE MAY HAVE BEEN DEFECTIVE. AS A RESULT, HE WILL UNDERGO ANOTHER SURGERY TO REMOVE/ REPLACE THE HARDWARE. WE HELD THE EXPLANTED HARDWARE IN THE LAB. ON (B)(6) 2014, THE PT CALLED IN FOR THE RESULTS IF AVAILABLE. THE HARDWARE WILL BE RELEASED TODAY ON (B)(4) 2014 TO THE SALES REP.: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762434 LRD SPINE ANCHORING PLATE OVD LDR SPINE MC - 1442 P 27009

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention