BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HELIPLUG

    MDR report key: 3129828 · Received May 21, 2013

    Report

    Report Number
    2523190-2013-00024
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    INTEGRA YORK, PA INC
    Product Code
    LPG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS THAT TWO PTS HAD TOOTH EXTRACTIONS AND DEVELOPED INFECTIONS. PHYSICIAN REPORTING BECAUSE LOTS ARE PART OF THE RECALL NOTICE RECEIVED FROM INTEGRA. (B)(6) 2013: DOCTOR REPORTS THE FOLLOWING: PT (B)(6), ON (B)(6) 2013: PT PRESENTED WITH COMPLAINT OF SWELLING UPPER RIGHT. EXAM SHOWS FRACTURED ROOT (MB) #3, ENDO TREATED AND PERIODONTAL ABSCESS. DIAGNOSIS: NON-RESTORABLE. TREATMENT: EXTRACT, GRAFT FOR BONE PRESERVATION AND IMPLANT. PT DEFERRED EXTRACTION THAT DAY FOR PERSONAL REASON. AMOX ANTIBIOTIC FOR SHORT TERM RELIEF. (B)(6) 2013: SCHEDULE FOR EXTRACTION. SURGICAL EXTRACTION VIA SPLIT ROOT TECH AND ROOT EXTRACTION TO CONSERVE BUCCAL PLATE AND REFLEX TISSUE. STRAUMANN ALLOGRAFT OCAN, HELIOPLUG OVER BONE, CYTOFLEX RESORB FOR CLOSURE. CLOSE WITH 3 X 3 SILK SUTURE. ONE WEEK FOLLOW-UP FOR SUTURE REMOVAL. (B)(6) 2013: PT COMPLAINS OF PAIN AND BAD TASTE FROM AREA. DR OUT OF OFFICE, AT MEETINGS. STAFF CALLED WITH PT'S COMPLAINT TO: ADVISE X-RAY (VIEWED REMOTELY) ANTIBIOTIC (AMOX 875 BID X 7 DAYS) AND RETURN ON DOCTOR'S TIME BACK IN OFFICE. (B)(6) 2013: EXUDATE IN SITE. DEBRIDE, IRRIGATE AND ANOTHER ROUND OF AMOX. (B)(6) 2013: HEALING WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225305 HELIPLUG NA LPG INTEGRA YORK, PA INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention