BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOFIL

    MDR report key: 17530670 · Received August 12, 2023

    Report

    Report Number
    MW5137588
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    October 20, 2015
    Manufacturer
    MEDTRONIC
    Product Code
    NEK
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    AUGUSTE, K., CHIN, C., ACOSTA, F., AND AMES, C., (2006) EXPANDABLE CYLINDRICAL CAGES IN THE CERVICAL SPINE A REVIEW OF 22 CASES. J NEUROSURG SPINE, 4: 285-291. THE AUTHORS DISCUSSED THEIR EXPERIENCE IN USING EXPANDABLE CYLINDRICAL CAGES (ECC) IN THE RECONSTRUCTION OF THE CERVICAL SPINE IN 22 PATIENTS WITH VARIOUS PATHOLOGICAL CONDITIONS. ALL PATIENTS UNDERWENT A STANDARD ANTERIOR CERVICAL CORPECTOMY. THE ECC CONSTRUCTS WERE SUPPLEMENTED WITH POSTERIOR INSTRUMENTATION IN PATIENTS WITH NEOPLASTIC PROCESSES OR THOSE REQUIRING TWO-OR MULTILEVEL CORPECTOMIES AND WITH A PREOPERATIVE KYPHOTIC DEFORMITY GREATER THAN 15?. THE SYNTHES IN-SPACE IMPLANT WAS USED FOR THE PERCUTANEOUS IMPLANTATIONS. NATIVE BONE HARVESTED FROM THE CORPECTOMY SITE WAS USED AS BONE GRAFT MATERIAL. IN PATIENTS WITH OSTEOMYELITIS OR METASTATIC CANCER THE COMPETITOR'S BONE MATERIAL PRODUCT WAS USED. OVERALL, THE COMBINATION OF CORPECTOMY AND ECG-AUGMENTED FUSION LED TO IMPROVEMENTS IN KYPHOTIC DEFORMITIES, RESTORING STRUCTURAL SUPPORT, AND APPEARED TO BE WELL TOLERATED. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050478 OSTEOFIL FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown