BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTERGRAFT PUTTY

    MDR report key: 3964723 · Received July 29, 2014

    Report

    Report Number
    1030489-2014-03336
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MQV
    PMA / PMN Number
    K071813
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER DEVICE NOR APPLICABLE STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LUMBAR SPINE SURGERY. POST-OP, THE PATIENT HAS SHOWN INTERMITTENT SYMPTOMS CONSISTENT WITH AN ALLERGIC REACTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442421 MASTERGRAFT PUTTY FILLER, BONE VOID, CALCIUM COMPOUND MQV MEDTRONIC SOFAMOR DANEK NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other