BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFTON PLUS¿ DBM

    MDR report key: 10464555 · Received August 28, 2020

    Report

    Report Number
    2246640-2020-00005
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Date of Event
    August 8, 2020
    Report Date
    August 28, 2020
    Product Code
    NUN
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT MARKETED IN US, HOWEVER A SIMILAR DEVICE WITH PRODUCT ID# T45010, 510(K)#: K043048, UDI#: (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. MANUFACTURING ASSESSMENT FIVE MANUFACTURING RECORDS WERE REVIEWED, AND NO DEVIATIONS WERE OBSERVED. NO NONCONFORMANCE¿S OR ROARS WERE OBSERVED FOR THE BATCH A42613-022 AND PART# T45010AUS. TEST REPORTS WERE REVIEWED (MED CLEANING OF WHOLE DONORS THAT WILL NOT YIELD SOFT TISSUE, BASE PROCESSING ROUTER, BULK TISSUE GRINDING ROUTER, GRAFTON PASTE REACTION ROUTER AND PASTE SYRINGE CORE PACKAGING ROUTER). ALL TESTS PASSED AND NO DEVIATIONS OR NON-CONFORMANCES WERE OBSERVED. HCPS REVIEWS: IN HCPS OPINION, THE ADVERSE EVENT WAS MOST LIKELY DUE TO SURGICAL TECHNIQUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CERVICAL DEGENERATION FOR SPINAL FUSION THERAPY AT C3-T2. IT WAS REPORTED THAT SOME OF THE PASTE WAS REMOVED DURING THE REVISION SURGERY, AS IT APPEARED THAT IT WASN'T FUSING TO THE BONE. THE PRODUCT WILL NOT BE RETURNED. THERE WAS NO POST-OP INFECTION, OR IMMUNOLOGICAL OR INFLAMMATORY RESPONSE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930090 GRAFTON PLUS¿ DBM BONE GRAFTING MATERIAL, HUMAN SOURCE NUN T45010AUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention