BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUIVABONE

    MDR report key: 3874351 · Received April 18, 2014

    Report

    Report Number
    1225112-2014-00001
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 12, 2014
    Report Date
    April 18, 2014
    Manufacturer
    ETEX CORP.
    Product Code
    MQV
    PMA / PMN Number
    K101557
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE 2 SEPARATE KITS THAT WERE USED FOR THE PROCEDURE - ONE 10CC EQUIVABONE (LOT# 101435) AND ANOTHER 10CC EQUIVABONE (LOT# 101449). BETWEEN THE (B)(4) AFOREMENTIONED LOTS THERE WERE (B)(4) KITS MANUFACTURED AND OUT OF THOSE (B)(4) HAVE BEEN IMPLANTED WITH NO INCIDENTS REPORTED. EQUIVABONE IS A PROPRIETARY CALCIUM PHOSPHATE BASED BONE SUBSTITUTE MATERIAL. EQUIVABONE ACHIEVES OSTEOINDUCTIVITY BY ADDING DEMINERALIZED BONE MATERIAL (DBM) TO THE SYNTHETIC CALCIUM PHOSPHATE. THE DBM IS DERIVED FROM DONATED HUMAN CADAVERIC BONE. THE DONATED BONE IS PROCURED AND PROCESSED BY A THIRD-PARTY SOURCE TISSUE BANK, ALLOSOURCE. THE RESULTING DBM POWDER IS PROCESSED SO THAT IT MEETS THE EXACTING SPECIFICATIONS DEVELOPED BY ETEX CORPORATION. EQUIVABONE FINISHED KITS FROM LOT #S 101449-0001 AND 101435-0012 WERE TESTED FOR HARDENING CHARACTERISTICS BY 2 SEPARATE METHODS. SUPPLEMENTAL TESTING DEMONSTRATES THAT THE HARDENING CHARACTERISTICS OF THE RESPECTIVE EQUIVABONE LOTS MEET SPECIFIED DESIGN REQUIREMENTS. EQUIVABONE FINISHED KITS FROM LOT #S 101449-0001 AND 101435-0012 WERE TESTED FOR HARDENING CHARACTERISTICS BY 2 SEPARATE METHODS. SUPPLEMENTAL TESTING DEMONSTRATES THAT THE HARDENING CHARACTERISTICS OF THE RESPECTIVE EQUIVABONE LOTS MEET SPECIFIED DESIGN REQUIREMENTS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, (B)(6) UNDERWENT A MINIMALLY INVASIVE L4 TO SL BILATERAL POSTEROLATERAL GUTTER FUSION WHERE IN THE PRODUCT WAS MIXED WITH BONE MARROW ASPIRATE FROM THE ILIAC CREST. ON (B)(6) 2014 TM COMPLAINED OF INCREASED PAIN. THE MRI SHOWED FLUID COLLECTION ALONG THE VERTEBRAL COLUMN. WHEN THE DOCTOR RE-OPERATED HE SAW A BROWN VISCOUS FLUID. AFTER THE FLUID WAS DRAINED, THE DOCTOR REPORTED THAT HE COULD NOT FIND THE BONE GRAFT WHERE HE HAD PLACED THEM 2 DAYS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238448 EQUIVABONE EQUIVABONE MQV ETEX CORP. 101435, 101449

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention