BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO - OSS

    MDR report key: 5236569 · Received November 16, 2015

    Report

    Report Number
    MW5057958
    Event Type
    Injury
    Date Received
    November 16, 2015
    Date of Event
    February 4, 2014
    Report Date
    November 16, 2015
    Manufacturer
    GEISTLICH PHARMA
    Product Code
    NPM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DR. (B)(6) OF (B)(6) USED BIO OSS, LOT #100412, TO FILL THE AREA OF EXTRACTED TOOTH #14 ON (B)(6) 2011. AFTER I MADE NUMEROUS REQUESTS TO PULL TOOTH #15 AS IT WAS INFECTED, PAINFUL AND VERY LOOSE DR. (B)(6) EXTRACTED IT ON (B)(6)2012. DR.(B)(6) TOLD ME I HAD SQUAMOUS CELL CARCINOMA IN THE #15, #14, #13 AREA ON (B)(6) 2014. THE CANCER, STAGE #4 SQUAMOUS CELL CARCINOMA, WAS CONFIRMED BY BIOPSY ON (B)(6) 2014. COMPLETE MAXILLARY BONE REMOVAL FROM #15 THRU #11 WAS PERFORMED ON (B)(6) 2014. DATES OF USE: (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757284 BIO - OSS DENTAL BONE VOID FILLER NPM GEISTLICH PHARMA 100412

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| S