BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERIOGLAS

    MDR report key: 263847 · Received February 18, 2000

    Report

    Report Number
    1056605-2000-00001
    Event Type
    Other
    Date Received
    February 18, 2000
    Date of Event
    January 27, 2000
    Report Date
    February 14, 2000
    Manufacturer
    BLOCK DRUG COMPANY, INC.
    Product Code
    LMO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DENTIST REPORTED THAT PT HAD A DECIDUOUS MANDIBULAR MOLAR IN THE AREA OF TOOTH #19 EXTRACTED. THE EXTRACTION SITE WAS GRAFTED WITH PERIOGLAS AND GORETEX MEMBRANE. THE DENTIST REPORTED THAT SHORTLY THEREAFTER, PT EXPERIENCED PAIN AND THE GORETEX MEMBRANE AND REMAINING PERIOGLAS WERE REMOVED. DENTIST REPORTS WAS NOT BEING THE TREATING DENTIST AT THIS POINT. THIS IS THE DENTIST'S REPORTED KNOWLEDGE OF THE PT'S HISTORY. DENTIST REPORTS PT'S FIRST VISIT OCCURRED SOMETIME BETWEEN 4-9 MOS AFTER THE PERIOGLAS WAS PLACED. PT PRESENTED WITH PAIN IN THE LEFT MANDIBULAR AREA, SMALL, REDDISH LESIONS ON THE ALVEOLAR GINGIVAL CREST, AND A LUMP, THE SIZE OF A SMALL FINGER, IN THE POSTERIOR LEFT CHEEK OVER THE EXTERNAL OBLIQUE RIDGE AND POSTERIOR BODY OF THE ANTERIOR RAMUS WHICH APPEARED TO BE WHITISH SOLID TISSUE. DENTIST WAS UNSURE OF THE TIME PERIOD AFTER WHICH PERIOGLAS WAS PLACED AND WHEN DENTIST FIRST TREATED THE PT. DENTIST REPORTED THAT AN INCISIONAL BIOPSY FOLLOWED BY AN EXCISIONAL BIOPSY WAS PERFORMED AND THE DENTIST NOTED THAT THE CHEEK TISSUE HARDLY BLED. IT FELT LIKE HARD LEATHER. THE DENTIST REPORTED THAT BIOPSY ANALYSIS REVEALED AMORPHOUS FOREIGN BODIES AND MULTIPLE CRYSTALLINE STRUCTURES. THE FIRST BIOPSY REVEALED PRIMARILY HIGH ALUMINUM CONTENT AND NO SILICA. THE DENTIST REPORTED THAT ADDITIONAL FOREIGN BODY ANALYSIS REVEALED CHRONIC INFLAMMATION. THE CONTENT OF THE CRYSTALLINE STRUCTURE WAS NOT REPORTED. DENTIST REPORTED THAT SOME TIME LATER, PT PRESENTED WITH ENTIRE INTRAORAL CHEEK THICKENED AND PAINFUL. THE DENTIST WAS UNSURE OF THE TIME PERIOD OF THE EVENTS. DENTIST REPORTS TREATING THE PT WITH ANTIBIOTICS WITH SLIGHT IMPROVEMENT IN SYMPTOMATOLOGY. DENTIST REPORTED THAT ONE WEEK LATER, THE PT PRESENTED WITH SWELLING OF THE UPPER LEFT LIP AND CANINE SPACE. DENTIST REPORTED THAT SOMETIME BETWEEN 7 TO 12 MONTHS AFTER PRODUCT PLACEMENT AND 1 DAY PRIOR TO THE DENTIST CONTACTING THE MFR, THE PT WENT TO THE HOSPITAL DUE TO ONGOING PAIN AND SWELLING AND WAS GIVEN STEROIDS AND DISCHARGED WITH A PRESCRIPTION FOR MEDROL DOSEPAK. DENTIST REPORTED THAT THE PT'S SYMPTOMS RESEMBLED ANGIONEUROTIC EDEMA. DENTIST REPORTED THAT THE HOSP FOUND NO EVIDENCE OF INFECTION OR ABCESS. THE DENTIST REPORTED THAT THE PT HAS ONGOING LEFT UPPER LIP SWELLING, LEFT FACIAL CHEEK SWELLING, INFLAMMATION, AND PAIN. THE DENTIST REPORTED THAT THE CONSUMER'S SYMPTOMS ARE DISTANT FROM THE INITIAL APPLICATION SITE, AND THE INITIAL TREATMENT SITE CONTINUES TO BE SYMPTOM FREE. THE DENTIST REPORTED THAT PERIOGLAS WAS INITIALLY PLACED IN TOOTH #19 WHICH IS THE LOWER LEFT FIRST MOLAR, AND THE PT IS EXPERIENCING SYMPTOMATOLOGY ON LEFT CHEEK AT LEAST 5CM AWAY FROM THE INITIAL TREATMENT SITE. DENTIST REPORTED THAT NO EVIDENCE OF PERIOGLAS WAS FOUND IN ANY OF THE BIOPSY ANALYSES. THE DENTIST REPORTED DIAGNOSIS AS FOREIGN BODY REACTIONS OF UNKNOWN ETIOLOGY. DENTIST REPORTED THAT PT HAS BEEN TO THE HOSP SEVERAL TIMES PRIOR TO THE LATEST HOSPITALIZATION DUE TO REPORTED SYMPTOMS. DENTIST DID NOT REPORT SPECIFIC DETAILS REGARDING THESE HOSPITALIZATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIOGLAS SYNTHETIC BONE GRAFT PARTICULATE LMO BLOCK DRUG COMPANY, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention