BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD

    MDR report key: 2822316 · Received November 7, 2012

    Report

    Report Number
    2520274-2012-02936
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 9, 2012
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IS REPORTED TO BE AGED IN HER (B)(6). INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO PART OR LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM AN ATTORNEY REGARDING A PATIENT WHO UNDERWENT A POSTERIOR-LATERAL FUSION AT T4-L3 ON (B)(6) 2011. THE PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2011 TO TREAT A COMPRESSION FRACTURE AT L-4 AND TO CORRECT PEDICLE SCREWS THAT WERE PULLING OUT (REPORTED UNDER SEPARATE COMPLAINT REPORT). THE ATTORNEY ALSO ADVISES THAT FURTHER HARDWARE PROBLEMS (SPECIFICS NOT PROVIDED) WERE NOTED IN (B)(6) 2011. THE PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2011 FOR POSTERIOR-LATERAL FUSION AT T5-S1. ALL HARDWARE WAS REMOVED AND THE PATIENT WAS REVISED TO A COBALT CHROME ROD. THIS IS REPORT #1 OF 4 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROD ROD NKB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ROD, SCREWS, SPINE IMPLANT