BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXOZ QUICKSET

    MDR report key: 3294671 · Received August 13, 2013

    Report

    Report Number
    3006761298-2013-00005
    Event Type
    Injury
    Date Received
    August 13, 2013
    Report Date
    August 8, 2013
    Manufacturer
    GRAFTYS
    Product Code
    MQV
    PMA / PMN Number
    K093343
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION COLLECTED IS BEING ANALYZED. THE SURGEON WHO DID THE SURGERY HAS RE-OPERATED THE PATIENT BECAUSE OF THE SUBGALEAL HEMORRHAGE, WHICH IS AN EXPECTED ADVERSE EVENT FOR THIS SURGICAL PROCEDURE REGARDLESS OF THE PRODUCT USED FOR FILLING THE CRANIAL DEFECT. THERE IS NO EVIDENCE THAT THE DEVICE IS THE CAUSE OF THE EVENT. IN ADDITION, THE PATIENT WAS (B)(6) YEARS OLD AND IT IS MENTIONED IN THE AXOZ QUICKSET IFU THAT "THE SAFETY AND EFFICACY OF AXOZ QUICKSET HAVE NOT BEEN ESTABLISHED IN THE FOLLOWING POPULATIONS: PATIENTS NOT HAVING REACHED BONE MATURITY." THE NECESSARY PROFESSIONAL INFORMATION WAS REITERATED TO THE USERS BY THE DISTRIBUTOR TO MAKE SURE THAT THE PRODUCT IS USED PROPERLY AND FOR THE RIGHT PATIENT.

    Description of Event or Problem · 1

    ONE OF OUR DISTRIBUTOR RELATED TO US THE FOLLOWING SITUATION: THE PATIENT WAS OPERATED FOR A CRANIOPLASTY REMODELLING DEFECT. THE SURGEON USED THE AXOZ DEVICE (16CC), BUT HE ONLY USED 8CC OF THE PRODUCT. HE WAITED UNTIL THE PRODUCT SET QUITE HARD AND USED 2 MINIPLATES TO FIX TO THE BONE. SURGEON WAS VERY HAPPY WITH THE IMMEDIATE SURGICAL POST-OP. AFTER 10 DAYS, THE PATIENT HAD AN SUBGALEAL HEMORRHAGE AND THE SURGEONS DECIDED TO RE-OPERATE. THE AXOZ DEVICE LOOKED LIKE SAND IN THE MIDDLE, BUT THE EDGES WERE OK. HE FINALLY USED A BONE CEMENT/AUTOLOGOUS BONE TO TREAT THE PATIENT DEFECT. NO MORE PROBLEMS WERE REPORTED AFTER THE REVISION SURGERY. THIS SITUATION OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388129 AXOZ QUICKSET GRAFTYS QUICKSET (K093343) MQV GRAFTYS 4922016 GQS3120613

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention NOT COMMUNICATED.