BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDUCTIGRAFT

    MDR report key: 9959258 · Received April 14, 2020

    Report

    Report Number
    1416980-2020-02171
    Event Type
    Injury
    Date Received
    April 14, 2020
    Report Date
    May 4, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MQV
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). LITERATURE ARTICLE: BOLGER, C., JONES, D., CZOP, S.¿EVALUATION OF AN INCREASED STRUT POROSITY SILICATE-SUBSTITUTED CALCIUM PHOSPHATE, SICAP EP, AS A SYNTHETIC BONE GRAFT SUBSTITUTE IN SPINAL FUSION SURGERY: A PROSPECTIVE, OPEN-LABEL STUDY¿. EUROPEAN SPINE JOURNAL (2019) 28:1733¿1742. HTTPS://DOI.ORG/10.1007/S00586-019-05926-1. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTION/ADDITIONAL INFORMATION: THIS IS A DUPLICATE REPORT TO THE REPORT UNDER MANUFACTURER REPORT NUMBERS: 2032282-2013-00057, 2032282-2013-00058, 2032282-2014-00116, 2032282-2014-00093, 2032282-2014-00116, 2954761-2012-00006, 2954761-2012-00005, 3004450973-2012-00014. ALL RELEVANT INFORMATION WAS SUBMITTED UNDER THE REPORTS 2032282-2013-00057, 2032282-2013-00058, 2032282-2014-00116, 2032282-2014-00093, 2032282-2014-00116, 2954761-2012-00006, 2954761-2012-00005, 3004450973-2012-00014. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 16 PATIENTS UNDERWENT A TWENTY-FOUR-MONTH STUDY IN WHICH AN UNKNOWN BAXTER SYNTHETIC BONE GRAFT SUBSTITUTE WAS USED WITH SPINAL POSTEROLATERAL FUSION SURGERIES. NINE PATIENTS EXPERIENCED BACK PAIN, FIVE PATIENTS EXPERIENCED SCIATICA AND TWO PATIENTS EXPERIENCED MYOSITIS. THE CAUSE OF THE EVENTS WAS NOT REPORTED. TREATMENT FOR THE EVENTS WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOMES WERE NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421330 INDUCTIGRAFT FILLER, BONE VOID, CALCIUM COMPOUND MQV BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other